Associate Director, Clinical Operations
Company: Lantheus Medical Imaging, Inc
Posted on: April 10, 2021
The Associate Director, Clinical Operations leads the planning,
conduct, and close-out of in-house and outsourced clinical studies.
The Associate Director is responsible for CRO / vendor oversight
and internal team management with a focus on study quality, data
integrity, and patient safety while maintaining established
timelines and budgets. The Associate Director is expected to
provide leadership within Clinical Operations and participate in
the strategic planning of function deliverables, timelines,
budgets, and resourcing. --Key Responsibilities/ Essential
- Provide leadership to study teams, work effectively and
efficiently with other functions in a cross-functional matrix
- Establish, monitor, and update study timelines and budgets,
including internal functions and vendors - escalating significant
risks or changes as appropriate.
- Contribute to the strategic planning of clinical programs.
- Serve as the primary Clinical Operations contact for internal
study team members and external stakeholders, and the escalation
point for investigator sites.
- Lead the vendor selection process - identifying potential
vendors and developing proposal requests.
- Oversee vendor activities and coordinate cross-functional tasks
to successfully achieve study milestones and quality
- Contribute and/or review the development of study-specific
plans, documents, and processes.
- Ensure studies are conducted in accordance with the protocol,
ICH GCP guidelines, governmental regulations, and applicable
- Track and report on study status including defined metrics and
key performance indicators.
- Assess risks to study performance, timelines, and budgets;
proactively plan risk mitigation strategies.
- Organize and participate in study meetings (e.g., study team;
- Perform ongoing assessments of operational efficiency and
communications; adjust study processes to optimize team
- Contribute to protocols, clinical study reports, annual
reports, key safety reports, and regulatory documents, as
- Participate in functional and cross-functional
- Perform other activities as assigned. Basic Qualifications
- Education: Bachelor's degree in science or related field
- Experience: Clinical research experience, with trial management
experience in industry (sponsor or CRO) is required. Vendor
management experience is required. Experience with oncology and/or
- Preferred: Master's degree or PMP certification. Monitoring
oversight or site management experience. Other Requirements
- Possess highly effective interpersonal and analytical skills
enabling influencing and negotiation skills
- Strong problem solving and decision-making skills
- Strong understanding of clinical trial methodology, drug
development process, ICH-GCP guidelines and applicable regulatory
requirements is required. Experience in clinical program
management, and clinical operations management of clinical trials
Well organized and detail oriented with strong written and verbal
communication skills. Highly proficient in MS Office
Keywords: Lantheus Medical Imaging, Inc, Fall River , Associate Director, Clinical Operations, Executive , Somerset, Massachusetts
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