System One Contract Sr Clinical Data Manager in Florham Park, New Jersey
Contract Senior Clinical Data Manager
Locations: Florham Park, NJ, USA (Hybrid work arrangements will allow work from home combined with your presence on-site 2-3 days/week (when not traveling) at US HQ in Florham Park, NJ.)
Support multiple studies either in-house or outsourced; provide CRO oversight (May operate as Lead Data Manager coordinating all Data Management tasks for the assigned studies. Supports decision making regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight.
Coordinate Database build, Design CRF, author/review Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines per agreed study timelines
Review and provide guidance/inputs to CRO for all outsourced Data Management activities including but not limited to CRF design, Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines.
Participate in User Acceptance Testing activities as needed.
Liaise with Safety team or Lab vendors and perform/oversee External data reconciliation and SAE reconciliation.
Conduct review/QC of clinical trial data; write/resolve queries and track the status of data cleanliness and perform all tasks required for database lock.
Respond and provide trial related support to cross functional groups such as Biostatistics, Clinical Research, etc.
Attend meetings and report on study status, metrics, timelines, etc.
Other data management department and trial related activities as delegated
MINIMUM JOB REQUIREMENTS
BA/BS in science related field
4-5 years of experience in clinical data management
Clinical data management background with various EDC systems
Strong Project Management skills
Excellent, verbal, written and interpersonal communication skills
PREFERRED SKILLS AND EXPERIENCE
Prior experience of working with studies across all phases or Clinical Development (Phase I – III). Specialized experience with Phase I studies or Post Marketing Surveillance studies or experience of working with Real World Data is a plus.
Familiarity with tools such as J review, SAS and Excel and proficiency with Electronic Data Capture systems preferably with Medidata Rave. Knowledge of e-source/ePRO/eCOA data is a plus.
Familiarity with CDASH, SDTM and medical terminology principles in relation to study design
Good working knowledge of GCP.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.