Clinical Data Manager
- Knowledge of pharmaceutical clinical drug development life cycle
- Ability to perform, supervise and coordinate all aspects of clinical trial data.
- Work closely with Clinical Operations, Clinical Science, Biostatistics, Drug Safety/Risk Management, and CROs.
- Responsible for study startup documents, data cleaning, DCF tracking, medical terms coding, database QC, compilation and maintenance of data management binders, AE reconciliation, and database lock.
- Responsible for the quality and timeliness of all data management activities for a study.
- Facilitate DCF resolution interacting directly with monitors and investigator sites.
- Identify errors and inconsistencies in CRF data and ensure their resolution.
- Develop and monitor study metrics, ensure appropriate training for the project team, and represent data management at investigator and team meetings.
- May lead and direct the work of others.
- Assist other Data Managers with operational tasks on other protocols.
- Assist in standardizing data management processes such as documentation for departmental operating procedures. Ability to communicate, plan, and organize data issues to data management project team
- Strong technical skills and knowledge of data management database systems and relevant computer languages (SAS, PL/SQL), OC, Clintrial
- EDC experience preferred (Inform, Rave)
- Strong attention to detail in composing materials, establishing priorities, scheduling and meeting deadlines. Project Management skills a plus.
- Bachelor's degree and 3-4 years of relevant data management experiences in biotech or pharmaceutical industry or CRO, including experiences in various phases of drug development.
- Need to be able to interpret and apply SAE/Coding/DM Guidelines and Data Handling Guidelines.
- Knowledge of FDA requirements and good clinical practices.
- Demonstrated leadership quality and superior organizational and interpersonal skills. Excellent communications skills a must.
- Knowledge of medical terminology, OC a plus.
About Assent Consulting
At Assent Consulting, we are known for the quality of our candidates and our service excellence. We expect the very highest standards of honor, honesty, quality and fairness from our consultants and associates. We accurately represent the skills and experience of our candidates as well as the requirements and responsibilities of each engagement. These core values have enabled us to develop strong, long-term relationships with expert consultants and leading companies that trust us with mission-critical projects
Assent Consulting delivers highly qualified consultants nationwide for companies in the pharmaceutical and biotechnology industries.
Indeed - 15 months ago