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Sr. Clinical Project Manager

Cambridge, MA 02139

Post Date: 08/16/2018 Job ID: 1762 Job Category: Clinical: Clinical Operations and Development

Responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.

Job  Responsibilities:
  • Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
  • Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
  • Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
  • Provides oversight and management of CROs, consultants and vendors.
  • Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
  • Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
  • Monitors the status of clinical data collection of assigned clinical trials.
  • Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
  • Prepares and reviews study-related documents when required.
  • Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
  • Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
  • Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
  • Reviews correspondences and monitoring reports relating to the studies.
  • Prepare and deliver program/study updates.
  • Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
  • Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
  • Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
  • Provides input into contracts, work orders and/or change orders.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
  • Ensures assigned studies adhere to all applicable regulations and requirements.
  • Provides input as the subject matter expert for the assigned studies during regulatory inspections.
  • Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
  • Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
  • Evaluate CRO and vendor performance and support the improvement initiatives.
  • Participate in the preparation, review, updating and training of SOPs.
  • Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.

Qualifications/ Requirements:
  • B.S./M.S./Ph.D. in a related life science discipline is preferred.
  • Thorough understanding of the oncology arena.
  • Minimum of five years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.

Kelly Rubach
Senior Clinical Recruiter

Kelly brings great energy and enthusiasm to her work as a Senior Clinical Recruiter for The Steely Group. She loves a challenge, thrives on problem solving, and is at her very best when she's uber busy. Kelly is tenacious; she believes there is one right person for every opportunity and will work tirelessly to ensure a perfect fit for every candidate and client.
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