Development Operations Manager (DOM) - H/F
AmgenFrance - parisUpdate time: December 1,2021
Job Description
Career Category
Clinical DevelopmentJob Description
Country leader of Global Study Operations / Site Management (GSO-SM) organization that is accountable for timely, quality clinical study delivery.
Actively partners with cross-functional stakeholders to support R&D strategy
Responsibilities
•Leadership of GSO-SM team in country
•Oversight of local strategy including feasibility and country operational plans
•Accountable for local feasibility activities and approve final site selection
•Review and approve forecast, baseline and re-baseline study targets
•Accountable for execution of clinical studies
•Ensure timely collection and validation of clinical trial data
•Responsible for timely, quality communication to both functional / cross-functional teams to support data monitoring, flow, and validation activities
•Partner with GSO-SM FSP and GCPM organization to monitor study progress and drive local action plans
•Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations
•Risk mitigation and quality management
•Proactively identifies risks and develops risk mitigation strategies to ensure operational effectiveness.
•Interpret analytics to monitor clinical study delivery (timelines, enrollment, data flow)
•Representing GSO-SM in internal and external stakeholder interactions
•Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP)
•Partner to maintain appropriate resource levels and manage within budget
•Supporting local and global process improvement initiatives
•Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations
•Engage local cross-functional teams (e.g. Medical, Scientific Affairs and GRAAS) to maximize local support of clinical trials
•Maintain relevant therapeutic knowledge and clinical research best practices.
•Participate in external industry activities (e.g. pharma associations, regulatory agencies)
Qualifications
Basic Qualifications
•BA/BS/BSc or RN
•Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
•Previous management experience of direct reports, including management level staff
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Preferred Qualifications
•M.D., D.O., PhD, Pharm D, Master’s Degree
•Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
•Country clinical operations experience and/or regional study management experience
Knowledge
•Advanced knowledge of global clinical trial management
•Clinical trial processes and operations
•Extensive knowledge of ICH/GCP, local regulations, clinical trial environment, requirements, and guidelines
•Project and Program management including oversight of quality, study deliverables, budgets and timelines
•Various therapeutic area knowledge
•Fluency in written and spoken English
•Clinical trial management systems and reporting tools
Competencies
•Strategic operational planning and cross-functional leadership
•Horizon scanning
•Risk assessment and risk mitigation
•Issue management and escalation
•Project management
•Analytical and problem solving skills
•Decision making
•Relationship management across geographic areas, including: networking, negotiation and influencing skills across all levels with both internal/external stakeholders
•Oral and written communication
•Organizational skills: planning, time management, prioritization, delegation
•Ability to work independently as well as in a team/matrix environment on multiple projects and countries
•Performance and people management
•Change management skills and learning ability
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