Senior Project Manager- Study Operations- Patient
hace 1 semana
- Development of Sponsor Project Plans (SPPs).
- Establish project startup timelines (including milestones, tasks lists, and dependencies) and track start
- Coordinate the development and communication of technical requirements to facilitate receipt of data transfers from sponsors; execute and test data transfers.
- Identify unique project needs including areas for internal development such as system enhancements. Assist in the related development of the internal tracking databases (see below, 'support and data management')
- Daily Clinical Support: Track and manage progress of the clinical review process. Support clinical to develop workflow processes including related training materials.
- Weekly Sponsor Reporting: Act as main point of contact to sponsor. Develop sponsor reports and presentation materials. Set up, organize, and participate in sponsor meetings and correspondence.
- Track and store all study correspondence and materials.
- Support finance in preparation of invoicing materials and reports.
- Assist Clinical team in preparation and review of the final study report.
- Support creation of backup files and storage of all project data (including: all clinical review systems data and study documentation).
- Support Quality Assurance by developing and documenting internal operations processes and SOP's and training employees on internal processes.
- Document and train on unique project computer systems; develop internal training materials and conduct internal training.
- Develop and document internal computer system requirements and enhancements.
- Coordinate and develop vendor contracts and statements of work, and facilitate communication between vendors and project teams.
- Test project specific systems and perform user acceptance testing.
- Proven problemsolving skills with strong attention to detail.
- A selfstarting mindset with excellent teambased interpersonal skills with the ability to work independently with the full spectrum of our people.
- Ability to build strong business relationships and influence with key stakeholders at all levels within the business.
- Ability to rapidly assimilate multiple types of information from a variety of sources for effective decision making.
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention and accuracy with details.
- Must be able to work in a fastpaced environment with demonstrated ability to effectively manage multiple tasks and projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree or equivalent.
- Strong preference of at least five years of work experience in the clinical trial space or at least two years of work experience supporting Rater Training or Rater Surveillance services
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