Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

BE - Clinical Pharmacology and Pharmacometrics Project Lead

Posted Aug 5, 2021
Job ID: JJJP00007342
Location
Beerse
Hours/week
40 hrs/week
Timeline
4 months
Starts: Aug 16, 2021
Ends: Dec 31, 2021
Payrate range
Unknown

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.


OVERVIEW:

  • Clinical Trial Management and Oversight for the activities of outsourced Phase I trials.
  • Lead Study Team meetings related to clin pharm outsourcing activities and ensures deliverables progress according to agreed upon timelines and milestones.
  • 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 Project Leaders will be given assignments that are more complex and/or have a greater potential impact on business results.
  • May contribute to process improvement and/or non-project work.



DUTIES & RESPONSIBILITIES:

  • Services rendered will adhere to applicable Johnson & Johnson 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
  • Primary interfaces: Clin Pharm Project Lead, Clin Pharm Leader, Clin Pharm Scientist, Clin Pharm Pharmacometrics Leader, Clin Pharm Business Support Group, Clin Pharm Group TA Head, Global/Local Trial Manager, CPP Vendor Staff.
  • Other Interfaces: Clinical Functional Trial Teams, Bioanalytical Teams, Functional Planners.



EXPERIENCE AND EDUCATION:

  • BS or MS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • 3 years clinical trial 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.
  • Good 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.


EXTRA INFORMATION:

  • Flexible working hours.
  • Because of COVID-19, you will work fulltime from home.
  • This is a long term contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Randstad Professionals. They can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.

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