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Associate Director/ Director, Clinical Project Management
2 months ago
POSITION SUMMARY:This is a full-time position responsible for overseeing all clinical program operational activities from start to finish for US and International studies with an initial focus on the upcoming Phase 3 program. The position will report directly to the Vice President, Project Management & Regulatory Affairs in collaboration with the Senior Vice President & Chief Medical Officer to execute clinical trials in a safe, ethical, high-quality and efficient manner.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead cross-functional project teams with an emphasis on clinical operation excellence, including but not limited to the conduct of regular meetings documented via meeting minutes as well as other means from study startup through completion of a clinical study report.
- Manages Sr. CRA and external regional CRAs, to ensure clinical research associates, inclusive of participating in regular meetings with CRAs and tracking/reviewing monitoring are reports, are interacting with clinical sites in accordance with the established monitoring plan and to facilitate tracking of key data points (e.g., deviations).
- Lead drafting, preparation and approval of key/required standard operating procedures, clinical study plans (e.g., monitoring plan) and manuals (e.g., laboratory manual).
- Support the development and administration of study budgets and accruals.
- Track enrollment and subject progress and report to Soligenix management regularly.
- Participate on the Corporate Compliance Committee.
- Lead tracking and review of protocol deviations to ensure issues are identified with appropriate CAPA put in place.
- Support the Medical team as needed, including but not limited to, facilitating safety review meetings, participating in eCRF development, etc.
- Participation in regulatory inspections as it relates to sponsor pre-approval inspection and investigational site inspections.
- Participate in the completion of clinical studies, and subsequent compilation and submission of Marketing Authorization Applications to regulatory health authorities, to be submitted in the electronic common technical document format (eCTD).
- Act as corporate representative coordinating with Data Monitoring Committees as needed.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum Bachelors Degree in medical field (e.g., nursing); advanced degree in field preferred (i.e., PhD, PharmD, MD).
- Knowledge of GCP, ICH, GLP and GMP.
- Proficient computer skills.
EXPERIENCE:
Minimum of 7 years of clinical research management experience. Previous experience conducting Phase 3 pivotal clinical trials is a plus.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
No physical requirements. Role would be located at Princeton Corporate Headquarters with an expectation that working from home may be permitted once per week.
OTHER SKILLS AND ABILITIES:
- Willingness to travel including international trips (estimated at up to 25% of time).
- Demonstrated experience managing multiple projects simultaneously with aggressive timelines.
- Demonstrated experience with management of Phase 3 multicenter/multinational clinical studies.
- Previous clinical monitoring/operations experience a plus.
- Demonstrated experience managing CROs and/or clinical monitors simultaneously with aggressive timelines.
- Experience and demonstrated ability to manage at a high level of productivity with minimum infrastructure.
- Proficient knowledge of MS Project and statistical software packages a plus.
- Proven verbal and written communication skills.
Soligenix, Inc. offers a competitive compensation and benefits package. Compensation will be commensurate with experience. Soligenix, Inc. is an Equal Opportunity Employer.
