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Senior Clinical Project Manager

Cambridge, MA

Posted: 05/11/2020 Employment Type: Contract Job Category: Clinical: R&D Program Management Job Number: 2552

Job Description


The Senior Clinical Project Manager is responsible for planning, implementation, and managing our client' s clinical trials. The Sr. Clinical Project Manager will work closely with internal cross functional teams and vendors.

Primary Responsibilities:
  • Plans and manages clinical projects while adhering to budget, scope, and timeline requirements
  • Manages and coordinates clinical budget and related pricing strategy services for the purpose of executing clinical trials or ancillary services agreements
  • Responsible for the execution of quality clinical trials from protocol design to the final clinical study report
  • Executes high quality, integrated cross-functional plans for the project/clinical trial
  • Ensures coordination of the activities of functional groups that comprise the clinical trial team for the project including, but not limited to clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to ensure proper conduct and timely completion of all projects
  • Manages CROs/vendors to ensure that performance expectations are met
  • Oversees clinical monitoring of the clinical studies including performing co-monitoring monitoring visits as necessary
  • Drafts study and site documentation as needed
  • Reviews clinical study data for completeness and accuracy
  • Develops innovative site activation and patient recruitment and retention strategies
  • Identify and recruit investigators in collaboration with the Medical Monitor
  • Maintains and oversees the electronic Trial Master File (eTMF)

 

Competencies:
  • MS/MA degree in science with 6 years of experience working in clinical trials.
  • BS/BA degree in science with 8 years of experience working in clinical trials.
  • Experience managing clinical trials including management of Contract Research Organizations (CROs)
  • Understanding of GCP, ICH guidelines, and regulatory requirements in clinical trials
  • Strong understanding of clinical operations and drug development
  • Experience in managing a cross-functional team
  • Proficient in computer technology including MS Office
  • Strong project management and organizational skills
  • Interpersonal and Communication Skills
  • Strategic Thinking
  • Collaboration and Teamwork
  • Excellent written and verbal skills
  • Ability to solve complex problems
  • Strong decision making skills
  • Ability to travel

Meet Your Recruiter

Heather Ward
Clinical Recruiter

Heather is driven by a passion for continuous growth and thrives by engaging with others. She brings an empathetic nature, customer-focused approach, and six years of recruiting experience to her role at The Steely Group.

This lifelong learner was first drawn to recruiting for the opportunity to impact and influence people’s lives. “Supporting my candidates and helping them achieve their professional goals is important to me,” she says. “It’s very rewarding to know that I’ve contributed to their success.”

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