Genentech- Clinical Research Study Leader- Passaic NJ 07424
12 months ++
Department: Early Research and Development
Therapeutic Areas of Expertise: Oncology & Cancer Immunotherapy, Infectious Diseases, Immunology, Neuroscience, Ophthalmology, Rare Diseases and Research Technologies
- Extensive experience leading Phase I and Phase II studies
- Phase II specific to more than one therapeutic area required. Developed leading clinical studies in pharma and/or biotech over the course of at least ten years.
- Previous experience working in biotech or pharmaceutical industries.
- Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with preference for early phase studies
- Direct experience overseeing multiple vendors and sites
- Global experience
- Conduct and monitoring of clinical studies (with preference for early phase studies)
- Archiving, Biomedical background, budgeting, case report forms
- Clinical Research, Clinical Studies
- Coaching, Contract Negotiation, Mentoring, Mitigation
- CRO data management, document management, documentation
- GCP, ICH, Life Sciences, Pharmaceutical, Development, Presentation Skills
- Project Management, Protocol Design, Risk Management
- SOP therapeutic training, vendor selection, feasibility QA
- Surface Mount Technology,
- Leads the cross-functional Study Management Team (SMT).
- Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.
- For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle.
- Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
- With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives.
- Conducts protocol and site feasibility assessments to ensure optimal site selection.
- Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
- Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline
- Study management experience in clinical or pharmaceutical development.
- Working knowledge of international regulatory and ICH GCP guidelines.
- Lead the most complex studies in the portfolio, will train associates must have prior management or mentoring responsibilities required.
All Study Leaders will be required to have:
- Sound understanding and appreciation of the scientific basis for different study types, ability to question scientific rationale and practical aspects of protocol design and to act as an equal partner for scientific team members.
- Strong leaderships and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies
- Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes.
- Experience of influencing and negotiating at all levels to achieve team delivery.
- Proactive management of risk mitigation strategies to troubleshoot foreseeable consequences to a variety of decisions made by a team or an individual
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