One of our leading Pharma clients is looking for a Clinical Pharmacology and Pharmacometrics Project Lead role in Beerse. This position starts with a 1,5-year contract; however, extension is expected.
- Services rendered will adhere to applicable the client 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.
- stablish 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
- BSc 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.
- 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 pre-empt budget issues and work with key stakeholders to resolve.
Project start date
Short notice preferred
18 months + possible extension / perm
If you are interested in the above description, please apply with your CV and a letter of motivation.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at email@example.com