A Scientific Program Manager role in Rockville, MD is now available through Adecco Medical and Science.
In this role, you will serve as a Program Manager for ACTIV-2 Clinical Trials.
Please note this is a 9-month contract-hire position starting in September 2021.
Responsibilities Effectively provide support to OPCRO OD, branches, and teams in the conduct of sponsor oversight for the ACTIV-2 trials.
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.
Education and Experience: Bachelor of Science degree, preferably in biological sciences.
Minimum at least 10 years of relevant experience in the field of clinical trials operation, including vendor oversight, leadership, and management of clinical trials.
If you have not received a degree, at a minimum (5) years of experience is desired.
Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy The Company will consider qualified applicants with arrest and conviction records