Associate Director, Clinical Operations

Company: Lantheus Medical Imaging, Inc
Location: Somerset
Posted on: April 10, 2021

Job Description:

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 Functions

• Provide leadership to study teams, work effectively and efficiently with other functions in a cross-functional matrix environment.
• 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 deliverables.
• 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 SOPs.
• 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; training; investigator).
• Perform ongoing assessments of operational efficiency and communications; adjust study processes to optimize team performance.
• Contribute to protocols, clinical study reports, annual reports, key safety reports, and regulatory documents, as required.
• Participate in functional and cross-functional initiatives.
• 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 radiopharmaceuticals required.
  • 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 applications

Keywords: Lantheus Medical Imaging, Inc, Fall River , Associate Director, Clinical Operations, Executive , Somerset, Massachusetts