Oversee the Data Management Department, including the writing of SOPs and CAPAs, as well as developing the department budget and forecast, and leading ongoing research, evaluation, and implementation of new data management, business intelligence, and visual analytics tools. Provide technical and administrative oversight for data management and biostatistics activities. Ensure compliance of the data management group with all relevant Good Clinical Practice (GCP) guidelines, Good Clinical Data Management Practice (GCDMP) guidelines, Standard Operating Procedures (SOPs), and any applicable regulatory requirements.
Responsibilities and Duties
Leadership responsibilities that included hiring new team members, conducting performance reviews, proactively contributing to new business development, and increasing the bandwidth of the data management team.
Serves as lead and subject matter expert for clinical data management related activities for assigned projects including protocol review, CRF/eCRF design, database build, testing and maintenance, project reporting, site training, and database lock.
Represents data management on project team calls, both internal and external.
Oversees the work of data management department members and provide guidance and support as needed.
Generates and reviews reports, listings, and other data management documents for distribution to clients.
Develops and reviews clinical study protocols, data management plans, and CRF Completion Guidelines.
Reviews project files for accuracy and provide ongoing Quality Control for data management projects and ensures that Trial Master Files (TMFs) for assigned projects are kept up to date.
Assists in the management of the data management department including personnel performance, budget setting and analysis, and other managerial tasks as assigned.
Identifies and provides training for junior department staff as needed.
Developments, implements, and delivers departmental training programs.
Interacts with other departmental staff including directors and project managers to ensure that project and department activities are successfully completed on time and within budget with a focus on accuracy.
Performs with vendor selection, evaluation and oversight.
Collaborates with other MCRA business units on business development initiatives, including proposal development and bid defenses.
Assists with all needed tasks to ensure timely and successful execution of projects including, but not limited to, database build and updating, Edit Check programming, User Acceptance testing and documentation, report building, and any other areas where work is required.
Evaluates and updates existing SOPs; writes new SOPs as business processes evolve.
Assists with FDA and internal project audits.
Potential for remote work flexibility for well-qualified candidate.
Master’s degree (M.A./M.S.) or equivalent in Data Management, Biostatistics, scientific, computer, or related discipline; relevant experience acceptable in lieu of Master’s degree.
None required; CCDM a plus.
At least 8-10 years of experience as a senior level clinical data manager (or above).
At least 2 years of supervisory experience in a clinical data management consisting of both oversight and hand-on project responsibilities.
Experience leading a Data Management team
Experience interacting with KOLs, C-Level executives, client stakeholders, etc.
Demonstrated knowledge and mastery of the conduct of data management and data management quality control activities necessary to ensure the success of a clinical study.
Proven independent problem-solving and leadership skills with the ability to manage competing priorities while maintaining a positive and professional attitude are a must.
Demonstrated advanced Excel skills.
Experience with Software as a Service EDC systems, for example IBM Merge, iMedNet, InForm, Medrio, Viedoc, ClinCapture OpenClinica or other SaaS EDCs where data managers are responsible for building and updating the database or a demonstrated aptitude for learning and mastering new software.
Comfort with the Base SAS programming language with direct experience writing and debugging SAS code as used for data management and/or SAS certification a huge plus.
Experience with data reporting tools and software desired.
Polished written and verbal communication skills
Internal Number: 2003
About MCRA, LLC
Founded in 2004, MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices.