Job Summary
The Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock, for clinical trials. This individual collaborates with the Clinical Project Managers (CPMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final databasedeliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Acorda regulatory and legal policies.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Participates in study planning and execution by contributing to the following activities in collaboration with Biostatistics and Clinical Operations: protocol review; case report form (CRF) design; CRF completion guidelines preparation; data management plan (DMP) development; database coding, transfer and edit check specifications review; user access testing (UAT) of electronic data capture (EDC) and interactive voice response systems (IVRS); data processing tracking; and data management document processing.
Collaborates with Clinical Project Managers (CPMs) and biostatisticians to generate requests for proposals (RFPs) from data management vendor evaluations and participates in bid defenses.
Works with external groups, including data management contract research organizations (CRO), laboratories, clinical trials centersand contractors regarding data management needs, and anticipates logistical issues of acquiring data from a variety of sources.
Ensures consistency, integrity and completeness of clinical databases by ensuring data management CROs, sites and other vendors are delivering quality data and documentation on time and according to quality standards.
Performs routine data review to ensure quality and identify data trends/issues.
Serves as the contact person and technical resource for CPMs on issues related to database design/implementation and data management processes arising during the execution of a study.
Oversees database and documentation change control and the finalization process for interim or final data analysis.
Contributes to the development, implementation and compliance to standard operating procedures (SOPs), work instructions (WIs)and guidelines regarding data management.
Coordinates resources to ensure all activities are completed in a timely manner.
Education and/or Experience:
Bachelors degree in life sciences, math, computer science or related field required.
Masters degree in life sciences, math, computer science or related field preferred.
Minimum of four to six years clinical data management experience.
Prior experience with biostatistics and SAS programming preferred.
Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
Qualifications:
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
Knowledge of study data tabulation model (SDTM).
Certificates, Licenses, Registrations:
Certified Clinical Data Manager (CCDM) certification preferred.
Computer Skills:
Must be proficient in MS Office Suite.
Other Skills and Abilities:
Must have excellent verbal, written and communication skills.
Ability to work independently as well as in a team environment.
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment.
Demonstrated ability to stay abreast of trends and new information in the profession.
Demonstrated leadership and project management skills.
This position will travel occasionally; the average travel for this position is 15-20% with some variation based upon the demands of the business imperatives.
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