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Job Description

JOB TITLE

DEPARTMENT
LOCATION
REPORTS TO
STATUS
COMPENSATION

MANAGER, CLINICAL TRIAL OPERATION

Clinical Research
Paramus, NJ
Director
Regular, Full-Time
Competitive

Job Summary Manage the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements.
Essential Duties and
Responsibilities
(Include but not limited to
the following.
Other duties may be assigned)
  • Assist to plan, implement, manage and report for regional or global clinical studies.
  • Manage selection process of CROs for regional or global clinical studies.
  • Manage the performance of study vendors (e.g. CROs and central labs)
  • Manage activities for clinical site selection, investigator meetings and study initiation.
  • Oversight of patient recruitment and development of recruitment strategies and plans
  • Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.)
  • Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans.
  • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols.
  • Coordinate negotiation of clinical trial contracts between investigational sites and CROs.
  • Manage data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan.
  • Support for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
  • Implement project specific training program and training materials
  • Support Creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes.
  • Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.).
  • As needed and required perform other tasks and functions.
Qualifications
  • Must be able to manage and coordinate with the Clinical Lead to achieve project objectives and able to manage/solve project management performance issues if they arise.
  • Demonstrated ability to support the development and management of various aspects of the end to end study operational plan.
  • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors.
  • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies.
  • Ability to handle multiple tasks and prioritize.
  • Strong organizational, communication and presentation skills.
  • Team player, flexible, ability to adapt to change.
Education and/
or Experience
  • Bachelor’s Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience.
  • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials.
  • Program and project management experience preferred.