We are seeking a Scientific Program Manager to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
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 DAIT and/or NIAID and additional relevant clinical data databases including those of DAIT's 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.
Qualifications
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.
Please submit your resume online at www.CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.
Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.
