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Associate Director, Clinical Operations

New Jersey All, NJ

Posted: 09/30/2018 Job Type: Clinical Job Number: JN -092018-22692
  • The Associate Director, Clinical Operations will lead the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission
  • He/she will lead the successful execution and timelines for clinical trials drawing on a high level of expertise with clinical and regulatory requirements, both local and international, for clinical operational processes and requirements
  • Lead overall operations program/team responsible for execution of global clinical trials
  • Oversee individuals managing operational execution of global clinical protocols
  • Provide clinical trial oversight and management, vendor and CRO performance (including bid/contract, budget/adjudication) and regulatory quality delivery of clinical trials according to corporate processes and timelines
  • Work collaboratively with internal and external staff associated with clinical operations as well as CROs and vendors associated with operational functions
  • Recommend and/or assess potential CROs and vendors in collaboration with Sourcing and other colleagues
  • Lead data review and discrepancy resolution, team meetings/presentations for a clinical trial with senior management, in the US, EU and Japan, as neededDefine and present complex operational objectives as required for senior management
  • Oversee data collection activities for clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, NDA etc.
Requirements:
  • BS or higher level degree
  • 10+ years of increasing responsibility in clinical operations in a pharmaceutical company or CRO with a strong background in clinical trial design
  • 5 years of line management experience
  • Successful experience in a large pharmaceutical company and complex matrix-based organization
  • Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA)
  • Expertise in clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes
  • Expertise in outsourcing and CRO management; outstanding budget oversight and adjudication skills
  • Highly analytical, scientific mind with exceptional problem-solving skills
  • Confident operations leader with proven ability to apply knowledge base to effectively manage, mentor and motivate staff in a matrix environment to achieve corporate objectives
  • Superior interpersonal skills coupled with multicultural awareness
  • Strong ability to build peer relationships and communicate effectively with company disciplines, cross-functional, and external teams
  • Able to successfully establish relationships, communicate effectively within/across company disciplines and thrive within a global, highly matrixed organization
  • Skilled at leading external teams at remote locations
  • Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials with short timelines in a fast-paced setting
  • Attention to detail and commitment to high quality and on-time deliverables
  • Outstanding computer skills including MS Office
  • Willingness to travel domestically and internationally
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