Unicon Pharma Released Job Openings On 24/01/2023.Unicon Pharma is a leading life sciences recruitment firm that provides services to top pharmaceutical, biopharmaceutical, biotechnology, and medical device companies nationwide. Our mission is to deliver the best experience for our clients and candidates on every engagement, big or small. Application form link provided at the end of post.
Unicon Pharma Recruiting B.Pharma,B.Tech Graduates required relevant experience for Senior Clinical Data Manager Position.Complete Details for the Senior Clinical Data Manager as follows.
Important Details :
- Location : United States (USA), Various Locations
- No of Vacancies:05
- Details of Salary:Not Disclosed
- Opening date for online Application: 24/01/2023
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- 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.
- 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.