Position Summary
The Senior Clinical Data Manager (Sr. CDM) will provide oversight of, assist in the coordination of, and/or partake directly in the data management activities from study start-up, data processing, and database close-out in a paper or electronic environment for projects where the activities are conducted in-house or by CROs. The Sr. CDM will report to the Director of Clinical Data Management and work closely with the Clinical team.
Key Duties and Responsibilities
• Responsible for data management activities supporting assigned clinical programs from database set-up through database lock and CSR/submission.
• Anticipate data management project requirements, institute, and manage appropriate actions to ensure timelines and project goals are met.
• Responsible for completeness, timely delivery, and quality of clinical trial data from programs.
• Participate in vendor evaluation, qualification, and selection, as needed.
• Serve as DM representative at study team meetings and as primary contact for internal departments and external vendors; develop, track, analyze, and provide regular status reports on vendor activities as well as internal data management performance metrics.
• Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors with respect to key performance indicators, metrics, and program level deliverables and timelines. Assess metrics for vendor quality and efficiencies, and escalate issues as needed.
• Participate in protocol design and review, providing key input related to the operationalization of the design and data collection, while ensuring consistency and that standards are followed.
• Develop or review key documents such as data collection instruments, database design specifications, Data Management Plans, Edit Check Specifications, data transfer agreements and specifications, SDTM mapping, CRF Completion Guidelines, Manual Review Guidelines, or Data Entry Guidelines.
• Develop User Acceptance Testing (UAT) plans, coordinate, and participate in UAT.
• Review site completed electronic case report forms (eCRFs) or paper CRFs for completeness and content.
• Review or perform external data reconciliation (i.e. laboratory data), and SAE reconciliation.
• Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues.
• Ensure proper closeout and archiving of data management study related materials, i.e. DMPs, database change documentation, validation documents, and final patient casebooks in paper or electronic format.
• Ensure compliance with all applicable laws, regulations, and regulatory guidelines.
• Understand and follow applicable SOPs. May contribute to the development and implementation of data management department policies, standards, and process improvement initiatives.
• Provide leadership, training, and support to new Data Managers as department grows.
• Keep abreast of literature and advancements in data management technologies, standards, and best practices while informing Clinical Department so they may be considered and/or applied to drug development programs.
REQUIREMENTS:
Desired Education, Skills, and Experience
• Minimum of Bachelor’s degree with 5 years experience, or Masters degree with 3 years of experience in the pharmaceutical or biotech industries.
• Strong knowledge in all aspects of data management from study start-up to study close.
• Knowledge of medical terminology, coding processes using MedDRA and WHO Drug dictionaries, and database design concepts.
• Working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC CDASH standards and SDTM/ADaM specifications.
• Excellent organizational skills with great attention to detail and the ability to multitask.
• Excellent verbal and written communication skills, as well as inter-personal skills and oral presentation abilities.
• Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Biostatistics, Medical, Safety, CMC, Translational Research, etc.)
• Strong vendor management and oversight skills.
• Ability to work proactively and effectively in a fast paced, high change environment.
• Proficient computer skills including MS office products.
• Diverse EDC platform knowledge and experience.
• The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize.
How to Apply:
Send cover letter with your resume to jobs@tmcsoftware.com.
