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FULLY REMOTE - Project Manager - Biostatistics

Company: Unassigned/Prospective Account
Location: San Diego
Posted on: September 16, 2021

Job Description:

The Project Manager of biometrics, you will be responsible for supporting the Biometrics team comprised of biostatistics, data management and statistical programming. You will be the owner of Biometrics timelines for upcoming regulatory submissions and ad-hoc requests needed for presentation outside of the company. You will help in the execution of processes created to work with the medical affairs team, and it will be your responsibility to ensure that RFPs are sent to vendors, SOWs are received from vendors and signed contracts are tracked. Collaboration with clinical operations to ensure alignment on studies is required. This role can be fully remote or sit on site in San Diego, CA.

Develop detailed timelines for regulatory submissions and ad-hoc work.

They will also set agenda for the meetings, record and communicate the action items, and follow-through on action items. Ensure that vendor timelines for biometrics are Integrated with clinicals timelines. They will ollaborate with clinical to ensure all the details on contracts and SOWs are available to the study team and participate in publication meetings and ensure processes are followed for ad-hoc requests. Manage publications from initiation, planning, execution, documentation, and submission. Ensure change orders are submitted to the contracts group and follow-up as needed so payment is submitted to vendors in a timely fashion. Help to keep the folders within Sharepoint organized and consistent between studies. Review invoices against vendor contracts and interface with Biometrics staff to ensure accuracy and satisfactory completion of deliverables. Assist Biometrics and Finance with budget/forecasting needs, such as accruals, project budgets, etc. Collaborate with Quality to ensure that all new vendors have audits set up prior to start of work.

- A Project Management Professional (PMP) Certification is preferred
- Bachelors degree with a minimum of 5 years experience in data management, biostatistics or statistical programming.

- Minimum 3 or more years experiences in Project Management in Biotech or pharmaceutical Industry performing submission work is required.

- Hands on experience working with BioStatistics

- Solid understanding of drug development and Biometrics

- Proven track record in managing multiple complex, large-scale projects with the ability to prioritize

- Working experience in managing resources and budget in Microsoft Excel

Keywords: Unassigned/Prospective Account, San Diego , FULLY REMOTE - Project Manager - Biostatistics, Other , San Diego, California

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