Are you an experienced clinical research professional with strong project management skills and profound phase I knowledge? Then this opportunity with our global pharma client may be your ideal assignment.
Clinical Trial Management and Oversight for the activities of outsourced Phase I trials. These services lead Study Team meetings related to clin pharm outsourcing activities and ensures deliverables progress according to agreed upon timelines and milestones. This service supports the Clinical Pharmacology and Pharmacometrics (CPP) Business Support Group. Interface with stakeholders; internal and external to CPP such as Clin Pharm Leader, Clin Pharm Scientist, Pharmacometrics leader, Global Trial Manager, Study Responsible Physician, Global Data Manager and vendor staff. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of CPP Project Lead colleagues. Advanced is given assignments that are more complex and/or have a greater potential impact on business results.
- Services rendered will adhere to applicable SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
- Complies with relevant training requirements.
- Lead the Phase I Study Team meetings including providing updates to key team members on Clin Pharm deliverables (i.e. Synopses, Protocols, Pharmacokinetic/Pharmacodynamic parameter generation, reporting) status.
- Assist with report preparation related to departmental resources, assignment and tracking of CPP deliverables.
- Manage timely and accurate documentation and communication of trial progress.
- Act as primary clin pharm outsourcing contact for assigned studies.
- Assist with creation of timelines, reviewer lists, organization of meetings and interact closely with cross-functional team to ensure appropriate content is available on time and with quality for trials and regulatory submissions.
- Ensure issue escalation and drive issue resolution.
- Ensure timely tracking of deliverables, forecasting of budgets and submission of contracts in appropriate systems, as required.
- Establish clin pharm outsourcing budgets and monitor actuals vs. forecast for Out of Pocket Expenses.
- Review and approve assigned vendor invoices/spend.
- Monitor budgets and expenditures as expected per planned trial budget.
- Contribute to process improvement and training, as applicable.
- Lead and/or participate in special initiatives, task forces, as assigned.
- Autonomy in oversight and management of clin pharm vendors
- BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- 4 years clinical trial management experience in the pharmaceutical industry or CRO.
- Strong working knowledge of ICH-GCP, local laws and regulations.
- Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of Phase 1 trials.
- Effective leadership skills and ability to manage multiple stakeholders.
- Experience and ability in coordinating global or regional teams and meetings in a virtual environment. Proven ability to foster team productivity and cohesiveness.
- Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required.
- Strong project planning/management.
- Independent complex decision making.
- Solution oriented and proactive risk identification and mitigation.
- Strong IT skills, including knowledge of standard Microsoft applications, and willingness to learn new systems.
- Ability to communicate effectively, verbally and in writing, to individuals and groups at various levels in the organization is required.
- Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
- Ability to understand and competently plan and have oversight of vendor budgeting processes, i.e. Understand and be aware of Out of Pockets (OOPs) and FTE cost drivers.
- Ability to proactively and autonomously identify and preempt budget issues and work with key stakeholders to resolve.
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17875