Clinical Pharmacology and Pharmacometrics (CPP) Project Lead

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 !

Job Description

The Clinical Pharmacology and Pharmacometrics (CPP) Project Lead will perform 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.

Responsibilities

• 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.
• Partner with the Clin Pharm Leader, Clin Pharm Scientist and/or Pharmacometrics Leader for outlining expectations and timelines for each study with outsourcing needs.
• 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.
• Ensure appropriate archiving and retention of documents per set requirements.
• Establish clin pharm outsourcing budgets and monitor actuals vs. forecast for Out of Pocket Expenses.
• Oversight of selected vendors and status of related deliverables.
• Review and approve assigned vendor invoices/spend.
• Monitor budgets and expenditures as expected per planned trial budget.
• Establish and maintain excellent working relationships with internal and external stakeholders.
• 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

Requirements

• 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 decision making. Solution oriented.
• 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.
• Existing right to work in Europe required

Benefits

• A balanced salary package based on your capabilities and experience, including extra legal benefits.

Vacancy number: 18359