Clinical Trials Program Manager
We are currently searching for a Clincial Trials Program Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and is on-site in Rockville, MD.
Duties & Responsibilities
- Effectively provide support to lab, 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 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 ACTIV-2 team to set priorities in accordance with applicable project plans, 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 lab operations.
- Ensure potential study risks are escalated to the attention of the branch chiefs/team leads and the Director, when appropriate.
- Track and follow up to resolution 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 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 lab policies, SOPs, and regulatory requirements.
- Bachelor's degree in a related subject or field.
- Minimum ten (10) years relevant experience in the field of clinical trials operations, including vendor oversight, leadership, and management of clinical trials.
- Experience creating standard operating procedures and coordinating compliance with staff members.
- Extensive tracking, prioritizing, and reporting experience (generating and reconciling*), highly preferred.
- Familiarity with the NIH organizational structure, its goals, objectives, programs, and policies desired.
- Excellent writing and communication skills
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.