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Clinical Trials Manager Consultant

Markent Personnel Richmond, British Columbia Full-Time
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TITLE: Clinical Trial Manager

6 month contract (renewable up to 4 years). Can also convert to perm/ FTE role. This role sits in their Richmond, CA office but can also work 2 days/week form their Brisbane, CA office

JOB SUMMARY:

The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job duties with guidance to ensure trial timelines, costs and quality metrics are met and the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.

ESSENTIAL FUNCTIONS:

Essential functions include, but are not limited to the following:

Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trial Lead cross-functional study team in support of study deliverables Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs Assist in preparation and review of clinical documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, case report form, statistical analysis plan, clinical study reports, and other study level documents Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews Participate and respond to Quality Assurance and regulatory authority inspection audits Responsible for and participates in service provider selection process as a part of outsourcing Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents Manage clinical trial budgets, providing ongoing financial reporting and projections Perform and manage data review process on an ongoing basis Negotiate and finalize site contracts and budgets Perform site visits including oversight, site qualification, initiation, monitoring and close-out visits, as needed Plan and coordinate Investigator Meetings

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

Bachelor’s, or equivalent, degree in a scientific discipline 6+ years of clinical research experience, with at least 2 years’ experience in planning and managing clinical trials Understanding of pharmaceutical regulatory requirements, both US and abroad Demonstrated knowledge of ICH and GCP Ability to independently manage the initiation, monitoring and closing of clinical studies in accordance with Client policies and procedures

• Understanding of clinical trial processes and experience in driving execution, from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing)

Self-motivated, assertive and able to function independently or as part of a team

• Experience in selection of investigative sites, CROs, and vendors and management of external resources

Highly effective communication and organizational skills Able to travel 25%-30%
 

Recommended skills

Medical Writing
Clinical Study Reports
Clinical Trials
Trial Master File
Good Clinical Practices (Gcp)
Clinical Research
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Job ID: 773468

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