Local Study Operations Manager
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Job Description
Local Study Operations Manager leading and managing clinical trials from start to finish. Collaborating with global teams to ensure quality and timely study delivery.
Responsibilities:
- Lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR/Archival) at a country level in accordance with ICH-GCP and other applicable local regulations
- Maintain the quality and scientific integrity of clinical trials at a local/country level
- Actively collaborate with cross functional internal and external partners to ensure timely delivery, budget implementation of clinical trial results within the local country
- Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery
- Communicate country status (including timelines and results) to key partners including updates to relevant systems for transparency
- Provide country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study
- Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management
- Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan
Requirements:
- Doctorate degree or Master’s degree and 3 years of clinical trial project management experience
- Bachelor’s degree and 5 years of clinical trial project management experience
- Associate’s degree and 10 years of clinical trial project management experience
- High school diploma / GED and 12 years of clinical trial project management experience
- Minimum 2-3 years’ experience of leading local/regional or global teams
- Minimum 2-3 years’ clinical trial project management experience
- 7 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 management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
- Must be a local/country expert with identifiable project management experience locally
Benefits:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
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