Clinical Data Manager (Contract)
Summary of Position
The Contract Clinical Data Manager leads data management activities for projects involving multiple and/or complex global clinical studies. This position requires strong data management knowledge and skills. The Clinical Data Manager must be able to work without close supervision and can coordinate the activities of CRO partners and other staff members.
This is a temporary (length TBD) 40 hr/wk position with primary activities geared towards study start-up (EDC and database development), eCRF data cleaning, QC and reconciliation of external data sources (PK, PD, etc.), maintaining data management documents (DMP, CRF completion guidelines, Data Validation Checks, etc.), and study close out (database lock) processes.
Roles and Responsibilities
The Contract Clinical Data Manager is responsible for:
Participating in CRO bidding and selection process for individual studies.
Overseeing CRO data management activities from CRF/database development through database lock and tables/listings generation; providing ongoing oversight of quality and timeliness of all CRO deliverables
Working with cross functional study management teams as a subject matter expert in the development of protocols, data collection forms (CRFs, diaries and CRF completion guidelines), clinical databases, study related data management documents, SOPs, etc.
Adhering to FDA regulations (21 CFR Part 11, GCP), ICH guidelines and internal SOPs
Ensuring the completeness, accuracy and consistency of data so that they meet the standards of quality expected for reporting to regulatory bodies.
Training clinical research associates on study specific issues to help improve the quality of data collection
Coordinating the appropriate formatting, conversion and transfer of external data such as PK and biomarker data
Communicating with other team members, reporting issues, and coordinating team meetings (as they related to data management study issues)
Tracking data management performance and providing routine and ad hoc project tracking reports as needed
Qualifications and Background Requirements
Minimum of a B.A/B.S. Degree in a relevant field required.
Minimum of 5 years of clinical data management experience, including database set-ups, data validation and consistency checks, initiation and closure of trial databases, CRF design, query resolution, review and reporting of laboratory and safety data,coding, and SAE reconciliation
Minimum of 2 years of experience managing Data Management activities outsourced to Contract Research Organizations (CROs).
Strong organizational skills and ability to work independently.
Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs.
Proficient in the use of clinical data management systems, including paper based and EDC systems, IVRS systems, and online enrolment
Excellent written and oral communication skills, including experience with production of requirements documents, technical specifications, and other components of a clinical study database development process
Strong attention to detail
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and to prioritize workload
Ability to work in a matrix environment and value the importance of teamwork
Ability to work farther across different departments in order to best move a study forward.
Knowledge of clinical data acquisition standards harmonization (CDASH)
Experience with SAS programming or relational databases a plus
Amicus Therapeutics, Inc.