: Early Development Clinical Trial Manager - Remote (JP9363)
Thousand Oaks, CA - Remote US Based
: 6-12 months with likely extensions
Job posting date
3 Key Consulting is hiring an Early Development Clinical Trial Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
The primary point of contact to lead, manage and co-ordinate the conduct of Phase 1/1b clinical trials from study design to close out at a global level in accordance with ICH-GCP.
- Lead the Clinical Study Team to drive effective decision making.
- Oversee the quality and scientific integrity of clinical operations for early development studies at a global level.
- Lead study level planning of the overall clinical operation, execute day-to-day operations of clinical trial at a global level and resolve issues escalated by the local study team.
- Develop early phase clinical operation strategy and contributes to the strategic scenario planning in clinical development plan.
- Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables.
- Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
- Manage vendors to the required standards.
- Contribute to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report.
- Manage study budget and timelines.
- Lead and coordinate Dose Level Review meetings, communicates decisions of the meetings, and operationalize meeting outcomes.
Why is the Position Open?
Planned project lead, manage and co-ordinate the conduct of Phase 1/1b clinical trials from study design to close out at a global level in accordance with ICH-GCP.
Top Must have Skill Sets:
- 6+ years’ work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
- Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
- Experience of collaborating and leading cross-functional global teams in a matrix environment.
Employee Value Proposition:
Opportunity to gain exposure to a large biotech industry. Exposure to a highly dynamic and cross functional team
Not having the following skills
- Experience managing global phase 1/1b or dose finding trials, preferably in Oncology
- Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.) and regional teams at the global level
- Experience of collaborating and leading cross-functional teams in a matrix environment
Virtual Panel interview through video.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role