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Jr Research Program Manager
Eingestellt von Synectics
Gesuchte Skills: Support
Projektbeschreibung
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
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Einsatzort:
New York, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges