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Project Manager, RTSM / IRT
Remote San Francisco, CA 94158 US
Job Description
This position is responsible for Supporting the Project Management of RTSM including (but not limited to) the design, implementation and ongoing management of RTSM (IRT).
- Provide advice/recommendation to study teams regarding system design alternatives.
- Provide leadership and subject matter expertise for the completion of set-up activities and through lifecycle of the system.
- Lead the cross functional study team through changes of scope, providing technical expertise, assessment of risk, oversight of system requirements updates and user acceptance testing
- Lead the resolution of issues escalated by study teams as well as cross-team specific issues
Define the data review requirements in collaboration with Data Management. - Participate in data management oversight reviews.
- Ongoing management of timely query resolution.
- Serve as the point of contact specific to inspection readiness activities between the study team and the RTSM supplier
- Support the study team in close-out/deactivation of the RTSM system
- Bachelor’s degree or equivalent experience required
- At least 6 years operational experience in clinical trials with a pharmaceutical
company and/or a Clinical Research Organization is required - Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required
- Familiarity with industry best practices for vendor management is required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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