Jr. Program Manager

The Program Manager ensures the timely review of proposals, contract generation and execution, and forecasts and coordinates drug shipments across the program globally. The PM also oversees study progress and collaborates with Associates to ultimately ensure compliance with processes, systems, and regulations.

- The Program Manager liaises externally with Principal Investigators, research sites, co-op groups, relevant government agencies, drug safety monitoring boards, alliance partners, and vendors. Internally, the Program Manager is the primary Point of Contact for colleagues.
- The Program Manager also monitors the related systems and educational needs of internal and external stakeholders to maintain compliance with policies and guidelines as well as external healthcare law throughout the process. The PM will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve functions globally across an asset program.

PRIMARY DUTIES:

- Manages requests from reception to close.
- Supervises initial review for completeness and classification of proposals, entry of information into the system, acknowledgment communications, and requests for additional information or documentation through the entire life cycle of assigned studies.
- Directs colleagues who are completing the submissions to address missing information and ensures compliance to policies on Safety Reporting, FCPA, and Privacy.
- Liaises with Business Units, Research Units, and Asset teams on proposals, especially those that will require or more sophisticated handling for review and decision. (eg, proposals from co-operative groups or partnerships).
- Updates study details and changes in supply and funding in the system, managing all approvals as required.
- Collaborates with Associates, as required, in processing complex studies with and clinical trial or sponsored study components.
- Coordinates and facilitates Review Committee(s)
- Informs Review Committees (for two or more assets) about meeting schedules and agendas and oversees document preparation for meetings.
- Manages and facilitates meetings of Review Committees for two or more assets, which review and make decisions about proposals.
- Ensures appropriate and efficient follow-up of Review Committee action items and decisions.
- Collaborates with internal and external partners and stakeholders
- Responds to queries about the status of assigned proposals, studies, and policies and procedures as required.
- Interacts directly with Principal Investigators, research sites, co-operative groups and public or private sector intergroups and networks in the US or worldwide to facilitate the Medical review process and execution of studies and to ensure compliance with policy, global and local healthcare laws.
- Works with the Training and Systems Liaison to communicate and resolve inquiries from internal and external stakeholders regarding the requirements of multi-site or multi-country studies.
- Coordinates with the Training and Systems Liaison to manage relationships with colleagues as required for management of proposals globally.
- Works with the External Partner Liaison to process requests and resolve issues and queries from internal or externals stakeholders regarding co-op or partnership group studies.
- Works with Reporting and Analytics Lead to provide detailed summaries and reports for asset or leadership and informs decisions on the management of programs.
- Mediates in the generation of contracts.
- Facilitates and monitors the efficient and accurate creation of contracts and amendments for studies - new or ongoing - with colleagues.
- Secures and manages clinical supplies and vendors.
- Forecasts study drug supply requirements, and initiates requests for clinical supply.
- Works with colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.
- Manages study drug supply inventories, and ensures timely deliveries to sites.
- Monitors study milestones and requests for additional supply and funding.
- Manages financial payments and tracks study progress and close
- Initiates initial and milestone payments, as appropriate, working to ensure accuracy and timeliness.
- Conducts enrolment sweeps on a regular basis to track patient enrolment and study progress.
- Resolve payment issues raised by investigators or other stakeholders, as required.
- Evaluates study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.
- Secures study results, required documentation, and publications from completed studies, forwards them as appropriate for
- Medical review, and implements Close procedures.
- Applies and provides training in operational strategies and compliance regulations
- Adheres to applicable SOPs, written standards, working practices, and implementation guidelines for the process, as required and contributes to their development.
- Trains colleagues on policies, procedures, and systems.
- Participates in task forces to evaluate and continuously improve processes and systems, as required and shares best practices.

SKILLS:

EDUCATION/EXPERIENCE

- Minimum of a BS/BA is required with preference for a focus in science or biomedical discipline. (Candidates with equivalent experience as defined below may be considered)
- Masters degree, Advanced education and/or training/experience preferred.
- Level will be determined by candidate's background and qualifications.
- Prior Experience in research or clinical study management is required.
- Experience with financial and drug supply forecasting.

SKILLS/QUALIFICATIONS:

- Demonstrated effectiveness in working in a multi-disciplinary, Matrix team situation, and demonstrated ability to manage change.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
- Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable.
- Strong working knowledge of the scientific and operational issues relevant to study design, drug product(s), disease characteristics, and relevant scientific and operational aspects of drug development.
- Solid understanding of GCP, Regulatory, Safety, and laws applicable to studies.
- Comprehensive knowledge of appropriate SOPs, processes and systems.
- Adept at the use of computer based tools and systems (eg, tracking, financial, document management, etc.) used to support study management.
- Excellent written and oral communication skills.
- Excellent project management skills; capable of managing two or more asset programs at the same time.
- MS Word.