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
Job is closed
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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