Junior Investigator Stellenangebote

Job vor 3 Tagen bei StepStone gefunden Bencard Allergie GmbH

Junior Medical Advisor (m/w/d) Corporate

• München Beratungs-/ Consultingtätigkeiten Absolventen, Einsteiger, Trainees Homeoffice möglich Abgeschlossenes Studium 30+ Urlaubstage [...] Firmenphilosophie aus. Wir denken AllerGOlogie weiter Jetzt kommen Sie ins Spiel: Begleiten Sie uns dabei, unsere Erfolgsgeschichte aktiv mitzugestalten und unsere Marktpräsenz weiter auszubauen Wir suchen Sie zum nächstmöglichen Zeitpunkt und in unbefristeter Anstellung für unseren Standort in München als Junior Medical Advisor (m/w/d) Corporate Bewertung wissenschaftlicher Publikationen sowie Unterstützung bei der Erstellung dieser in deutscher und englischer Sprache (Medical Writing) Aktive Teilnahme an und Repräsentanz von Bencard bei in-und externen Veranstaltungen, Schulungen, Präsentationen und wissenschaftlichen Kongressen Mitarbeit am Aufbau von medizinischen KI-Projekten sowie unserer professionellen Social-Media-Präsenz Unterstützung bei der Organisation und Durchführung von europaweiten Firmenveranstaltungen wie Kongressen, Symposien, Investigator Meetings und Advisory Boards Mithilfe im Kontakt und bei der Kooperation mit externen Experten Cross-funktionale Zusammenarbeit mit globalen sowie lokalen Abteilungen (u. a. Medical, Clinical, Market Access, Pharmakovigilanz, Regulatory Affairs, [...]

Job vor 2 Tagen bei Jobleads gefunden Medical Science Liaison Manager Neph, Nord-Ost • München, Bayern [...] with key medical experts within the assigned region and become recognized and educate the medical community with up-to-date medical and scientific information Identify and execute collaboration opportunities between expert KOLs and Alexion medical affairs and clinical development such as publications, investigator-initiated trials, regional advisory boards, training and speaker development programs. Communicate experts opinion, feedback on new data and clinical trends to [...] Job function Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x Sign in to set job alerts for Medical Science Liaison roles. Hybrid: Medical Advisor Medical Science Liaison (m (f/d) Junior Medical Advisor (m/w/d) Corporate Scientific Affairs Manager-Germany (Southwest) Medical Advisor/ MSL (Austria based) (f/m/d) (Senior) Regional Medical Affairs Managerin Respiratory [...]

Job am 01.06.2025 bei Jobleads gefunden

Senior/ Medical Director (Dermatology) (m/f/d)

Führungs-/ Leitungspositionen Senior/ Medical Director (Dermatology) (m/f/d) Join to apply for the Senior/ Medical Director (Dermatology) (m/f/d) role at TFS Health Science Senior/ Medical Director (Dermatology) (m/f/d)[...]

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[...] the primary authority on medical issuesproviding clear, informed guidance and answering complex questions related to medical, legal, and regulatory concerns. Key Responsibilities Expert Guidance: Provide advanced medical input on study design, measurement strategies, and trial protocols, including safety sections and investigator brochures. Comprehensive Safety Oversight: Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports from [...] Management Plans. Medical Monitoring Signal Detection: Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation. Regulatory Document Contributions: Offer expert medical insight into regulatory submissions and safety-related documentation. Team Client Engagement: Mentor junior medical staff, support SOP/ tool development, and join Commercial Operations in client meetings and presentations. Qualifications Medical Qualifications: Medical Doctor [...]
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Job am 23.05.2025 bei Jobleads gefunden Senior/ Medical Director (Dermatology) (m/f/d) • Hamburg, Berlin Führungs-/ Leitungspositionen [...] the primary authority on medical issuesproviding clear, informed guidance and answering complex questions related to medical, legal, and regulatory concerns. Key Responsibilities Expert Guidance: Provide advanced medical input on study design, measurement strategies, and trial protocols, including safety sections and investigator brochures. Comprehensive Safety Oversight: Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports from [...] Management Plans. Medical Monitoring Signal Detection: Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation. Regulatory Document Contributions: Offer expert medical insight into regulatory submissions and safety-related documentation. Team Client Engagement: Mentor junior medical staff, support SOP/ tool development, and join Commercial Operations in client meetings and presentations. Qualifications: Medical Qualifications: Medical Doctor [...]

Job am 23.05.2025 bei Jobleads gefunden Senior/ Medical Director (Dermatology) (m/f/d) • München, Bayern Führungs-/ Leitungspositionen [...] primary authority on medical issuesproviding clear, informed guidance and answering complex questions related to medical, legal, and regulatory concerns. Key Responsibilities Expert Guidance : Provide advanced medical input on study design, measurement strategies, and trial protocols, including safety sections and investigator brochures. Comprehensive Safety Oversight : Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports [...] Monitoring Signal Detection : Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation. Regulatory Document Contributions : Offer expert medical insight into regulatory submissions and safety-related documentation. Team Client Engagement : Mentor junior medical staff, support SOP/ tool development, and join Commercial Operations in client meetings and presentations. Qualifications : Medical Qualifications : [...]

Job am 17.04.2025 bei Jobleads gefunden Medical Director Führungs-/ Leitungspositionen [...] for assigned products, ensuring timely identification and communication of safety issues. Serve as the medical safety expert on cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs. Author and review key safety documents including DSURs, PSURs/ PBRERs, RMPs, and investigator brochures. Contribute to the development and maintenance of risk management strategies and benefit-risk assessments. Participate in regulatory interactions and inspections, providing expert input on safety-related matters. Support clinical trial safety monitoring, including medical review of SAEs, and provide input into protocols and informed consent forms. Mentor and guide junior safety physicians and scientists. Qualifications: Medical degree (MD or equivalent) is required. Minimum of 7 years of experience in pharmacovigilance/ [...]
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Job vor 11 Tagen bei Jobleads gefunden

Clinical Research Associate

Work-Life-Balance RQM+ is The Med Tech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and[...]

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[...] accordance with Good Clinical Practice/ ISO 14155 and procedures set forth by RQM+ and sponsors. Works closely with the Project Manager and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements. Primary Responsibilities: Participates in the investigator recruitment process and performs site qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and [...] external meetings, as required. Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study level study management system. Ensures all study deliverables are completed per RQM+ and study timelines. Serves as mentor for junior staff and those new to the company and/or study. Performs other duties, as requested. Requirements: University/ College degree (life science [...]
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Job am 05.06.2025 bei Jobleads gefunden German Speaking Junior Social Media Content Moderator-Lisbon • Stuttgart, Baden- Württemberg Absolventen, Einsteiger, Trainees Are you a German speaker? Are you ready to pack your bags and kick-start your career in Lisbon? We are looking for German Junior Social Media Content Moderators to start their career in Digital Marketing and Online Advertising. Responsibilities : Provide B2B support to [...] to engineering Requirements Native or proficient level of German (C2) Advanced level of English both verbal and written Strong communication skills with excellent phone conversation skills, attentive listening and superior writing skills Desire to learn and advance, be a curious investigator and problem solver Experience with online advertising products and social media will be considered a plus Must hold EU citizenship [...]

Job am 28.05.2025 bei Jobleads gefunden

Junior Clinical Research Associate

• München, Bayern Absolventen, Einsteiger, Trainees [...] specifically be responsible for the following: Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians and their site staff; Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report [...]

Job am 23.05.2025 bei Jobleads gefunden Head of an independent Junior Research Group in Target Screening and Immunoreceptor Engineering f. . . • Würzburg, Bayern Führungs-/ Leitungspositionen Absolventen, Einsteiger, Trainees Jobticket Job Description Research for a life without cancer is our mission at the German Cancer Research Center. We investigate how cancer develops, identify cancer risk[...]

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[...] methods for tumor diagnosis and cancer treatment. Every contribution counts whether in research, administration, or infrastructure. This makes our work meaningful and exciting. For the next possible date, the German Cancer Research Center (DKFZ) seeks a Head of an independent Junior Research Group in Target Screening and Immunoreceptor Engineering for Immunotherapy at NCT WERA (Würzburg site) . Reference number: 2025-0128 The [...] sites and DKFZ Heidelberg. PhD in life sciences or MD in medicine Excellent postdoctoral research experience (up to 6 years) , ideally in target screening or immunoreceptor engineering Strong publication record Ability to manage research projects and develop ideas for Investigator Initiated Trials (IITs) Motivation to secure third-party funding and lead a growing research group Independent leadership and mentoring skills Willingness [...]
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Job am 18.05.2025 bei Jobleads gefunden

Associate Principal Scientist, Drug Safety

• München, Bayern Associate Principal Scientist, Drug Safety Join to apply for the Associate Principal Scientist, Drug Safety role at Organon Associate Principal Scientist, Drug Safety 2 days[...]

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[...] the TA lead, the authors of the safety science contribution to global regulatory submission documents required for filling applications for new products, formulations, or indications (briefing books, Benefit-risk Assessment BRA) , and all associated documentation (e. g. , informed consent, investigator brochure) . Collaborating with GMS and the appropriate functional areas, and with strategic guidance from the TA head, reviews, provide [...] meetings with the Safety Science Physician and produces regulatory supporting documentation for labelling updates. In partnership with the DSL responds to manufacturing or device-related queries requiring safety health hazard evaluation writing and safety position communication. May coach and train more junior Safety Science personnel in signal evaluation methodology, risk management and preparation of safety reports and other documents. May lead process [...]
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Job am 17.05.2025 bei Jobleads gefunden Leiterin Projektmanagement-Sponsor-Studien (Klinische Studien/ IITs) • Berlin Homeoffice möglich Flexible Arbeitszeiten Tarifvertrag Ort: Berlin Leiterin Projektmanagement Sponsor-Studien (Klinische Studien/ IITs) Die Fraunhofer-Gesellschaft (www. fraunhofer. de) betreibt in Deutschland derzeit 76 Institute und Forschungseinrichtungen und ist eine der[...]

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[...] Entwicklung von besseren Lösungen für Patientinnen mit Allergien und anderen Mastzell-vermittelten Erkrankungen. Für den Auf-und Ausbau eines Sponsor-Teams für klinische Studien suchen wir eine leitungserfahrene und engagierte Persönlichkeit. Was Sie bei uns tun Als Kopf eines Projektmanagement-Teams zur Durchführung von Investigator Initiated Clinical Trials (IIT/ Sponsor-Verantwortung) leiten Sie den Aufbau, die Weiterentwicklung, Etablierung und aktive Umsetzung eines Konzepts für klinische Studien, [...] als Sponsor auftritt. Sie übernehmen die Sponsor Oversight, den Review von Key-Performance-Indikatoren (KPIs) und erstellen sowie aktualisieren den Projektplan. Des Weiteren verantworten Sie die Einhaltung vertraglicher Vereinbarungen, inklusive Scope of Work und Budget innerhalb der Sponsor-Studien. Sie tragen Führungsverantwortung für (Junior) Projektmanagerinnen und Data-Managerinnen. Sie begleiten unser Qualitätsmanagement bei Prozessen sowie bei Projektabläufen und erstellen gemeinsam SOPs, Prozessbeschreibungen und Arbeitsanweisungen für [...]
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Job am 12.04.2025 bei Jobleads gefunden

Senior Scientist, Biology for AITHYRA (m/f/d)

• Wien Homeoffice möglich [...] to elucidate mechanisms of small molecule action, with an emphasis on TPD and transcriptional regulation. Mentorship Supervision: Co-supervise PhD students and starting postdoctoral fellows, offering scientific guidance on experimental strategies and data interpretation. Grant Writing Documentation: Partner with the Principal Investigator to develop grant proposals, annual reports, and other funding-related materials. Fellowship Support: Provide expertise and editorial support to PhD students [...] with postdoctoral experience in functional genomics or other scalable technologies. Strong publication track record with at least two first-author publications Familiarity with grant writing and the capacity to contribute to competitive proposals. Demonstrated leadership and mentoring abilities, with experience guiding junior scientists are considered a plus Excellent communication written and oral communication skills as well as high accuracy, reliability and excellent [...]
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Job am 01.02.2025 bei Jobleads gefunden Sr Site Contracts Specialist Homebased Germany or Austria • Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen [...] lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor [...] a fast-paced environment Good vendor management skills Strong organizational skills with proven ability to handle multiple projects Excellent communication, presentation and interpersonal skills Quality-driven in all managed activities Strong negotiating skills Strong problem-solving skills Ability to mentor and motivate more junior staff Demonstrate an ability to provide quality feedback and guidance to peers Contribute to a training and Quality assurance plan [...]
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Job am 29.12.2024 bei Jobleads gefunden

Clinical Research Associate (Germany)

[...] This is a remote based position (homebased anywhere in Germany) , with travel to sites for monitoring visits. About you: You are calm, thoughtful, and responsive when things dont go as planned. You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game. You find quick and creative [...] helping prepare regulatory submissions, conducting pre-study and initiation visits, etc. ) . Senior CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations. [...]

Job am 16.05.2025 bei Neuvoo gefunden TFS Health Science Senior/ Medical Director (Dermatology) (m/f/d) • Munich, Bavaria Führungs-/ Leitungspositionen TFS Health Science is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.[...]

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[...] the primary authority on medical issuesproviding clear, informed guidance and answering complex questions related to medical, legal, and regulatory concerns. Key Responsibilities Expert Guidance: Provide advanced medical input on study design, measurement strategies, and trial protocols, including safety sections and investigator brochures. Comprehensive Safety Oversight: Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports from [...] Management Plans. Medical Monitoring Signal Detection: Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation. Regulatory Document Contributions: Offer expert medical insight into regulatory submissions and safety-related documentation. Team Client Engagement: Mentor junior medical staff, support SOP/ tool development, and join Commercial Operations in client meetings and presentations. Qualifications: Medical Qualifications: Medical Doctor [...]

Job am 16.05.2025 bei Neuvoo gefunden TFS Health Science Senior/ Medical Director (Dermatology) (m/f/d) • Hamburg Führungs-/ Leitungspositionen [...] the primary authority on medical issuesproviding clear, informed guidance and answering complex questions related to medical, legal, and regulatory concerns. Key Responsibilities Expert Guidance: Provide advanced medical input on study design, measurement strategies, and trial protocols, including safety sections and investigator brochures. Comprehensive Safety Oversight: Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports from [...] Management Plans. Medical Monitoring Signal Detection: Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation. Regulatory Document Contributions: Offer expert medical insight into regulatory submissions and safety-related documentation. Team Client Engagement: Mentor junior medical staff, support SOP/ tool development, and join Commercial Operations in client meetings and presentations. Qualifications: Medical Qualifications: Medical Doctor [...]

Neu Job vor 6 Std. bei NewScientist Jobs gefunden Oaks Healthcare Clinical Services Manager • Waterlooville, Hampshire, United Kingdom, Hampshire Job summary We are seeking an enthusiastic clinical manager to join the management team at the surgery to build on our clinical and administrative governance[...]

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[...] the individual. To adhere to all safeguarding matters in accordance with local and national policies. Maintaining safe levels of clinical working within the department and undertaking clinics if necessary. Training and educating staff on clinical topics. To be a named investigator on all clinical research work and supervise research clinicians performing the role. Managerial Responsibilities In addition to the clinical responsibilities, [...] collaboratively with the Practice Ops manager with all complaint processes. Develop clinical protocols in line with the needs of the patient and current legislation. Undertake financial responsibility as directed by Business Manager. Demonstrate positive role model behaviours and supervision to junior team members. Job description Job responsibilities Job Description The post holder is responsible for ensuring the delivery of safe and [...]
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Neu Job vor 6 Std. bei NewScientist Jobs gefunden Bei Gene, Inc.

Senior Clinical Research Associate

• United Kingdom [...] Clinical Operations Study Lead to ensure study timelines are adhered to and required quality standards are maintained, mentor and manage CRAs. Essential Functions of the job: The following functions may apply based on study and program requirements; Mentor and manage junior staff and Clinical Research Associates Acts as the escalation point person for CRA (s) with site related issues and concerns [...] per monitoring plan and applicable SOPs Conducts co-monitoring visits, if required Conducts Quality Oversight Visits (QOV) or other monitoring visits, as requested Completes monitoring visit/ QOV reports timely Documents monitoring activities appropriately following ICH-GCP and Bei Gene standards Assists with investigator/ site identification Provides protocol and related study training to assigned sites Manages site performance by tracking regulatory submissions, recruitment, case [...]

Job vor 2 Tagen bei NewScientist Jobs gefunden Rho Inc Clinical Research Associate II/ Sr. CRA, United Kingdom • United Kingdom Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. We are[...]

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[...] a permanent CRA II/ Senior CRA role to be home based role in the UK. Responsibilities: May contribute to the development of study tools and materials as well as documentation for clinical trials May provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members May provide support to the RFP process Prepare and perform all onsite off-site/ remote [...] applicable regulations and Sponsor requirements under supervision of experienced staff Effectively documents observations in site visit reports and follow up letters within timelines required by Rho s procedural documents and the applicable clinical monitoring plan Prepare (if needed) and maintain Investigator Site Files (ISF) , and maintain site binders and documents of the TMF (Trial Master May assist in payment processes, [...]
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Job vor 4 Tagen bei NewScientist Jobs gefunden Takeda Pharmaceutical Company Limited Senior Scientific Director, Clinical Pharmacology • Boston, Massachusetts, United States, Boston Führungs-/ Leitungspositionen By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application[...]

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[...] advance program progression and support regulatory submissions. Oversee outsourcing collaborations, including contracts, Statement of Work (SOW) , budget management, and invoice approvals. Engage directly with regulatory agencies, representing clinical pharmacology in global regulatory meetings; contribute to regulatory deliverables, such as Investigator Brochures (IBs) , product labeling, responses to regulatory queries, and filings while ensuring alignment with regulatory strategy. Author and review [...] Reports, as well as related sections of Clinical Study Reports (CSRs) . Participate in business development evaluations by conducting due diligence and assessing potential opportunities. Uphold Takeda s commitment to Good Clinical Practices (GCP) , compliance, and ethical standards. Mentor junior team members, fostering scientific excellence and supporting professional growth. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: A Ph. D. , Pharm D, [...]

Job vor 10 Tagen bei NewScientist Jobs gefunden University Hospital Southampton NHS Trust Clinical Research Fellow in Palliative Care • Southampton, United Kingdom, Hampshire Homeoffice möglich Job summary University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us. This is a FIXED TERM Contract[...]

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[...] for detailed job description of the role. Main duties of the job Join a small team delivering research within Palliative Medicine-there will be a need and opportunity to work largely independently on delivery of trials with oversight from the Principal Investigator You will have roles in managing, coordinating and safety governance for specific Palliative Medicine trials. Be responsible for specific study-related [...] National Medical and Dental pay circular. Basic salary detailed below plus any additional remuneration (as applicable) for hours set out in the doctors work schedule (e. g. additional hours, weekend allowance, and any hours which attract enhanced pay) Basic Salary Junior Fellow: MT03 49, 909Basic Salary Senior Fellow: MT04 61, 825 or Basic Salary MT05 70, 425 Salary will be assessed [...]
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Job vor 12 Tagen bei NewScientist Jobs gefunden Syneos Health Careers Sr CRA II-Part time (18.75hr per week) • Farnborough, United Kingdom, Hampshire Teilzeit Description Sr CRA II-Part time (18.75hr per week) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate[...]

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[...] operating procedures Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities Ensure trials are conducted in accordance with regulatory requirements and company standards by performing [...] subject/ patient safety and clinical data integrity Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF) Document activities via [...]
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Job vor 12 Tagen bei NewScientist Jobs gefunden The Christie NHS Foundation Trust Senior/ Junior Haematology Clinical Trials Research Fellow • Manchester, United Kingdom, Greater Manchester Absolventen, Einsteiger, Trainees Detailed job description and main responsibilities ORGANISATIONAL ARRANGEMENTS This post is for 32 hours per week to provide a Clinical Fellowship within Haematology Research. Role[...]

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[...] for individuals who wish to gain further experience in experimental medicine Phase I trials, including first-in-human trials. A diverse range of clinical research trials are in progress following training, the post holder will participate in these studies as a co-/ sub-investigator. These include Phase I trials of small molecule inhibitors, combination/ multi-modality Phase I trials, and trials of CAR-T and bispecific [...] the existing Palatine ward Haematology clinical team ensuring that all patients across the department have optimal daily clinical cover. Working as part of the existing ward team which includes 2 Haematology ST doctors, 1 TYA Oncology Senior clinical fellow, 1 Junior Oncology fellow and 3 x ward-based IMTs who cover the 31 bedded-ward. . The haematology fellow will have a particular [...]

Job vor 12 Tagen bei NewScientist Jobs gefunden Syneos Health Careers Sr CRA I (CRA II or Sr CRA II) • Farnborough, United Kingdom, Hampshire Description Sr CRA I (CRA II or Sr CRA II) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] processes, programs, and policies, including participating in the development of clinical trial protocols and providing input on study design and methodology Manage and direct the work of lower-level professionals or manage processes and programs, including providing guidance and support to junior staff members and overseeing the day-to-day activities of clinical trial sites Ensure accurate and timely documentation and reporting of clinical [...] subject/ patient safety and clinical data integrity Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF) Document activities via [...]