Location: Chatham, NJ
Description: Our client is currently seeking a Senior Clinical Data Manager
- Support or Manage multiple studies in-house and provide CRO oversight (May operate as the Trial Data Lead (TDL) depending on study needs).
- Coordinate Database build, Design CRF, author Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines for an inhouse study.
- 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 and perform/oversee SAE reconciliation.
- Conduct review 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.
- Assist in developing SOP and Working Practices.
- Attend meetings and report on study status, metrics, timelines, etc.
- Other data management department and trial related activities as delegated.
Entails decision making responsibilities regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight.
- BA/BS in science related field.
- 4 plus years' experience in clinical data management.
- Clinical data management background with EDC systems.
- Strong project management skills.
- Excellent, verbal, written and interpersonal communication skills.
- Flexible work arrangements will allow for work from home, but we suggest you live a commutable distance to our offices in Florham Park, NJ to allow for your convenience on days when you do need and/or want to work onsite.
- PREFERRED SKILLS & EXPERIENCE
- Prior experience working with studies across all phases or Clinical Development (Phase I - III).
- Specialized experience with Phase I studies, and/or Post Marketing Surveillance studies, and /or experience 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.
- Experience in RBM, or Centralized Monitoring is preferred.
- Good working knowledge of GCP.
This job and many more are available through The Judge Group. Find us on the web at www.judge.com