Scientific Program Manager
We are currently searching for a Scientific Program Manager to provide support to the National Institutes of Health (NIH). This opportunity is a part-time position with MSC, and it is on-site in Rockville, MD.
Duties & Responsibilities
- Gain and maintain a comprehensive understanding to ACTIV3 protocol and, as requested, other COVID-19 protocols.
- Identify and obtain resources needed to establish and maintain the International Coordinating Center as high-functioning and capable of meeting and exceeding the INSIGHT requirements for its ICCs.
- Provide senior level oversight of the work of the program team including setting deadlines. Identify and resolve barriers to task completion.
- Provide assistance and guidance to executive level management.
- Provide recommendations to leadership for decisions / actions related to the program.
- Assist with the development and implementation of ICC operational framework including processes, leveraging existing INSIGHT ICC procedures and processes whenever possible and appropriate.
- Assist with the development and implementation of the strategy for coordination of clinical trial operations in concordance with leadership.
- Ensure adequate resources are available for the following areas of trial management
- Human Subjects Protection
- Regulatory Adherence
- Support sites that are conducting or are interested in conducting the trial(s) in identifying and resolving gaps in staffing.
- Review enrollment and determine areas of need.
- Develop strategies to increase enrollment.
- Develop strategies to optimize site participation and adherence to protocols.
- Liaise with other agencies and organizations when necessary. Liaise with consultant groups to optimize performance.
- Support the program in identifying potential sites for participation in the trial(s).
- Participate in engagement with, and addition of, new sites.
- Develop and implement standard operation procedures for trial implementation.
- Participate in clinical trial agreement negotiations and discussions with sites and networks.
- Participate in the Quality Assurance/Quality Control processes.
- Prepare reports for leadership as requested.
- Assist with developing budgets and monitoring costs.
- Master’s degree in related field or equivalent experience
- Minimum of twenty (20) years’ experience in related field
- Expertise in management and operations
- Expertise in the fundamentals of clinical trials
- Experience with IRB and FDA requirements
- Experience in clinical research setting with protocols and clinical trials
- Excellent writing skills.
- The position will involve frequent interaction between NIH Federal and other contract staff, and sites interested in, or engaged in ACTIV3 or other NIH COVID-19 clinical trials. Interactions include activities that require continuity, a high level of collaborative problem solving, and time-sensitive decision making.
- Will be required to handle proprietary information in the strictest confidence and shall be bound by the same terms as the Government in this respect.
- Will ensure representation in all required conference/video calls as a critical communication platform for all aspects of the program.
- Fluency in English; Spanish and other languages, useful.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.