CPP Project Lead

Location Beerse
Discipline: Pharmaceutical
Contact name: Sayf Idais

Contact email: s.idais@panda-int.com
Job ref: 12324
Published: 17 days ago

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.
 

Responsibilities:

 

  • 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
 

Requirements:

 

  • 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

 

Project duration

18 months + possible extension / perm

 

Interested?

 

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 s.idais@panda-int.com