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

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

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

Local Study Operations Manager

Key skills