Senior Clinical Data Manager
The Senior Clinical Data Manager works closely with the multidisciplinary project team across the life cycle of the study to ensure data management is thoughtfully planned and delivered in a consistent, timely, and high quality manner. He/she is a key contributor to project success through development and utilization of innovative tools to help automate manual tasks and identify data trends in a timely fashion and constant collaboration with project peers, particularly biostatisticians, statistical programmers, and clinical operations personnel. The Senior Clinical Data Manager also independently performs and oversees completion of data management tasks to ensure clinical database design supports study outcomes; proactively clean clinical trial data and mitigate risks; effectively communicate data-related decisions to sponsors; and to ensure data management activities follow all applicable standards and study-specific procedures.
- Provides DM functional leadership to deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the trial.
- Interfaces with the project team and sponsors across the lifecycle of the project to proactively ensure data integrity and quality.
- Mentors more junior DMs and other project team members on areas related to data management.
- Effectively presents information and responds to questions from sponsors, senior managers, project team members, and clinical trial sites.
- Makes strategic decisions and recommendations related to the data that benefit the project as a whole.
- Ensures compliance with standard operating procedures.
- Manages database design, development, testing and system validation for new studies.
- Has the expertise to do tasks independently and/or to oversee and mentor others in task completion.
- Leads design of eCRF and reviews with study team to ensure design is robust and minimizes risk. Works particularly closely with the lead statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design.
- Creates and implements data management plans (DMPs), data validation plans (DVPs), and other study documents. Ensures that the project team is trained and has a shared understanding of how data will be cleaned and each person’s role in the process.
- Leads electronic data capture (EDC) system design and validation, including oversight of all database specifications (eCRF design, edit checks, external data transfers, IWRS integration, etc.).
- Reviews and approves creation of all edit checks, including validation of simple univariate and multivariate edit checks, programming of complex multivariate validation checks, and UAT of system edit checks. Ability to write simple edit checks using SAS or similar languages is a plus.
- Creates and maintains data transfer agreements with external vendors and leads external data cleaning activities.
- Reviews recommended data management tools and selects the best tools for the study, leveraging study metadata and automation to minimize manual error and facilitate deeper understanding of study data.
- Trains site personnel on EDC system, eCRF, and additional tools such as ePRO when needed.
- Uses data cleaning tools to issue, review, and close queries and to identify data trends and potential issues early in the study, and implements intervention plans with project team to address issues.
- Holds periodic multidisciplinary data reviews with the project team to review data trends and anomalies, and to proactively address risks.
- Follows-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure.
- Conducts or oversees completion of all activities for database lock, ensuring data integrity and adherence to applicable regulations.
- Ensures all study materials are finalized in an eTMF and archived for delivery.
- BA/BS degree and a minimum of 5 years of clinical data management experience with approximately 1-2 years in a DM lead role. 1-2 years of experience in developing clinical trials databases in a commercially available EDC system (e.g. RAVE, Medrio, RedCap, Veeva)
- Medidata RAVE build certification 5.6.4 a plus.
- Strong analytical skills with a demonstrated ability to identify trends in data and use insights to manage risks and drive decisions.
- Strong technical acumen, with experience selecting, customizing, and using various tools for data base build and data cleaning.
- Demonstrated programming skills, particularly experience in SAS or Business Objects IX, is a plus.
- Experience importing/cleaning external data transfers.
- Excellent verbal and written communication and interpersonal skills.
- Must be a self-starter, able to work independently and have the ability to coordinate multiple activities simultaneously in support of various projects.