Scientific Program Manager – NIH – OPCRO, DAIDS
# of Openings 1 Category NIAID Type Regular Full-Time
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We are seeking a Scientific Program Manager (OPCRO) to support the overall functions of the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) for the ACTIV2 clinical trial.
- Effectively provide support to OPCRO OD, branches, and teams in the conduct of sponsor oversight for the ACTIV-2 trial.
- Proactively manage ACTIV-2 project level operational aspects, including management of timelines, action items, resources, and vendors.
- Provide efficient updates on trial progress to the Office Director with respect to Office related activities, project plans, trial and project timeline management, quality standards, and risk mitigation.
- Ensure effective project plans are in place and operational and work proactively with the DAIDS ACTIV-2 team to set priorities in accordance with applicable project plans, DAIDS’ policies, standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Assist in tracking activities for ACTIV-2 with respect to protocol implementation and individual assets/investigational products.
- Support tracking of manufactured agents related to the trial against facets of OPCRO operations.
- Ensure potential study risks are escalated to the attention of the branch chiefs/team leads and the OPCRO Director, when appropriate.
- Track and follow up to resolution OPCRO ACTIV-2 issues, ensuring they have been completed in a timely manner.
- Monitor the quality of vendor deliverables, escalate quality issues to the appropriate team member, and identify opportunities to improve training, execution and quality control across the Office with respect to ACTIV-2.
- Participate in routine OPCRO meetings to discuss ACTIV-2 quality issues, sponsor oversight activities, and planning for process improvements.
- Review and approve vendor responses to quality concerns against raised issues for appropriateness, timeliness and accordance with DAIDS policies, SOPs, and regulatory requirements.
- All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.
- At least 5 years of relevant of experience years in the field of human subject protection and policy development.
- The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract.