Clinical Operations Program Manager
We are currently searching for a Clinical Operations Program Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Rockville, MD.
Duties & Responsibilities
- Act as subject matter expert (SME) for all data management activities including proper data entry and tracking, human subject’s protection, data confidentiality and related IT security.
- Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by the program and additional relevant clinical data databases including those of clinical research organization (CRO) awardees, ImmPORT and ClinicalTrials.gov.
- Provide expertise to sponsor clinical data management projects on multiple complex studies and programs, both internal and performed by supporting clinical research organizations (CROs).
- Provide technical oversight of CROs performing core data management functions including case report form (CRF)/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
- Responsible for the oversight of clinical data management study deliverables, evaluating and mitigating data management risks.
- Provide expertise to assist in CRF and database design.
- Assist in the development and implementation of data transfer and migration plans relating to transitions between CROs.
- Perform or oversee development of clinical data management validation plans, data transfer requirements and agreements, and data management plans.
- Provide expertise in support of developing sponsor data management SOPs, procedures, PWIs, Plans, Guidance and other quality-related documentation.
- Devise and oversee implementation of quality assessment procedures according to data management plans and other means.
- Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing.
- Assist with the creation and review of CAPAs related to clinical data management.
- Review and process clinical trial data to ensure data quality for data analysis.
- Participate in clinical study data reviews and other activities related to database lock.
- Participate in multi-party clinical data process development initiatives.
- Assist in the development of data pathways and system interconnection arrangements.
- Provide input on clinical data management system enhancements including design, review, performing user acceptance testing and validation supporting activities.
- Master’s degree in a related discipline required. A Ph.D. in a related discipline a plus.
- At least five (5) years of clinical data management experience is required.
- Excellent verbal and strong written communication skills are required as this person is expected to interact with team members from various disciplines every day.
- Excellent analytical, organizational and time management skills required.
- Thorough understanding and experience with GCP/GxP, Privacy Act and quality requirements are required.
- A working knowledge of clinical data management tools is required.
- Experience programming and using Medidata Rave, Oracle Argus and RedCap preferred.
- Familiarity with clinical trial data standards such as CDISC preferred.
- Experience in developing eCRFs and clinical databases required.
- Experience creating and evaluating clinical data management plans and agreements preferred.
- Experience working within a quality-driven environment is preferred.
- Experience creating and evaluating SOPs and CAPAs required.
- Systems validation experience preferred.
- Knowledge of data systems architecture and structure of data systems is required.
- Pharmaceutical industry experience a plus.
- Excellent computer skills, proficient in Microsoft Office, SQL and XML required.
- Experience with statistical software such as R, SAS, Stata, & SPS preferred.
Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.Company Description
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.