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- Norwalk, CT
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Associate Director Of Clinical Operations
Apex Systems • Norwalk, CT
Posted 10 days ago
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Client Job Description:
Title: Associate Director, Clinical Operations
Reports to: VP of Clinical Operations
Location: Norwalk, CT
Position Overview: The Associate Director of Clinical Operations will provide completed management and oversight for INDs. Associate Director of Clinical Operations is responsible for all aspects of study conduct and CRO oversight and is the primary point of contact for clinical study project management, communications, and will assume a high level of decision-making authority. Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and regulatory components is essential.
Specific Job Functions/Responsibilities:
- Ability to manage complex protocols within a matrix environment.
- Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required.
- Demonstrated ability to drive clinical trial activities: i.e. experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, budgeting.
- Manage all clinical aspects of the study, including responsibility for oversight of study execution, develop and manage comprehensive study timelines and metrics; management/oversight of external vendor deliverables reports and budgets.
- Report on all aspects of the study progress to management
- Provides study-specific training and leadership to clinical research staff, including CRO, sites and other contract personnel.
- Provide leadership and serve as the clinical trial subject matter expert.
- Oversees the following groups across the trial program: CRO, clinical supplies, DM, outsourcing and vendor alliance management.
- Primary contact for Consortium Pharma Partners.
- Ensure Pharma Partner trial reporting requirements are being met.
- Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Study Management Meetings, site calls etc.).
- Study budget management and oversight of vendor and site payments. Liaise with finance group on budget expense projections and payment reconciliation. Review and approve clinical invoices against approved budgets.
- Ability to identify and manage or escalate risks.
- Review and sign off on monitoring reports, ensure study issues and action items are addressed and closeout appropriately and in compliance with study management plans.
- Daily interaction with study CRO project manager, the medical monitor and other members of the cross-functional study team.
- Prepares and/or reviews study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).
- Provide input on operational components of legal documentation and statements of work as required for new and returning sponsors, vendors and suppliers.
- Write and review study protocols, informed consents and amendments.
- Excellent working knowledge GCP, FDA and ICH Guidelines. Ensures the assigned clinical trials are executed in compliance with FDA and ICH GCP guidelines/regulations and SOPs.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Excellent team player; willingness and ability to fill functional gaps in a small organization.
- Preference to energetic candidates with a desire to think “outside the box”.
- Minimum degree requirements of a Bachelor’s Degree (BA, BS) in scientific or health care discipline preferred.
- Demonstrated ability to multi-task and manage high performance demands
- 10 + years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Effective oral, written and interpersonal communication skills.
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project)
- Hematology oncology Therapeutic Experience preferred.
- CRO oversight experience
- Experience working in (CRO/Pharma) required
- Strong leadership skills
- Strong organizational skills
- Ability to travel as necessary (approximately 10%)
- Multiple Myeloma experience required*
For immediate consideration, please apply and email resume to email@example.com with 'Associate Director- 957536 ' in the subject line.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178