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Evolution Research Group logo
Evolution Research Group

Quality Clinical Research Today for a Healthier Tomorrow

Clinical Research Project Manager

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 501-1,000Since 2014H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

82 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Clinical Research Project Manager

Evolution Research Group

• Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities. • Manage and execute the overall project scope, budget, and timelines. • Identify project success factors for analysis, reporting, and tracking. • Manage resources and timelines associated with all study start-up and implementation activities. • Lead the development of study specific protocols, consent forms, and other trial related materials as required. • Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies. • Participate in the review of clinical data for analysis. • Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs). • Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated. • Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices. • Monitor adherence to project contract and budget. • Coordinate with clinical, business development, and operations management to identify goals and scope of clinical study projects. • Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. • Support the management and oversight of clinical study related vendors. • Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements. • Enhance department and organization reputation by participating in departmental or corporate initiatives. • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. • Attend off-site meetings and conferences, as needed.

Job Requirements

  • Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
  • CRO experience is highly desirable.
  • Experience managing external vendors preferred.
  • Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies preferred.
  • Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process preferred.

Benefits

  • 100% Remote

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