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Jr Research Program Manager

Eingestellt von Synectics

Gesuchte Skills: Support

Projektbeschreibung

The Research Program Manager has primary responsibility for the oversight and management of Research programs within assigned Therapeutic Area(s). This will be in support of at least two or more Medical Teams in the Business Units and/or Research Units that review and approve research proposals from independent investigators in the corresponding therapeutic areas.

PRIMARY DUTIES:

- Manage requests from reception to close.
- Supervise initial review for completeness and classification of proposals, entry of information into the system, acknowledgment communications, and requests for additional information or documentation.
- Direct colleagues who are completing the submissions to address missing information and ensure compliance to policies on Safety Reporting, FCPA, and Privacy.
- Liaise with Business Units, Research Units, and Asset teams on proposals.
- Update study details and changes in supply and funding in the system, managing all approvals as required.
- Collaborate with Associates in processing complex studies with and clinical trial or sponsored study components.
- Coordinate and facilitateReview Committee(s).
- Inform Review Committees about meeting schedules and agendas and oversee document preparation for meetings.
- Manage and facilitate meetings of Review Committees which review and make decisions about proposals.
- Ensure appropriate and efficient follow-up of Review Committee action items and decisions.
- Collaborate with internal and external partners and stakeholders.
- Respond to queries about the status of assigned proposals, studies, and policies and procedures.
- Interact with Principal Investigators, research sites, co-operative groups, public or private sector intergroups, and networks to facilitate the Medical review process and execution of studies to ensure compliance with policy, and healthcare laws.
- Work with the Training & Systems Liaison to communicate and resolve inquiries from stakeholders.
- Coordinate with the Training & Systems Liaison to manage relationships with colleagues.
- Work with the External Partner Liaison to process requests and resolve issues and queries from stakeholders.
- Work with Reporting and Analytics Lead to provide detailed summaries and reports for leadership.
- Mediate the generation of contracts.
- Facilitate and monitor the efficient and accurate creation of contracts and amendments for studies.
- Secure and manage clinical supplies and vendors.
- Forecast study drug supply requirements, and initiate requests for clinical supply.
- Work with colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.
- Manage study drug supply inventories, and ensure timely deliveries to sites.
- Monitor study milestones and requests for additional supply and funding.
- Manage financial payments and track study progress and close.
- Initiate initial and milestone payments, as appropriate to ensure accuracy and timeliness.
- Conduct enrolment sweeps on a regular basis to track patient enrolment and study progress.
- Resolve payment issues raised by investigators or other stakeholders as required.
- Evaluate study progress reports and results for overall compliance and recommend corrective action or study termination for non-performance.
- Secure study results, required documentation, and publications from completed studies, forward them for Medical review.
- Apply and provide training in operational strategies and compliance regulations.
- Adhere to applicable SOPs, written standards, working practices, and implementation guidelines, and contribute to their development.
- Train colleagues on policies, procedures, and systems, as directed.
- Participate in task forces to evaluate and continuously improve processes and systems, and share best practices.
- Provide end-to-end management of processes for multiple asset programs from review to implementation and close.
- Bring results to the appropriate attention of Medical to demonstrate ROI.

SKILLS:

TRAININGcapable of managing two or more asset programs at the same time.
- MS Word.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Synectics