Principal Clinical Data Manager
Job Description SummaryThe Principal Clinical Data Manager will lead all data management aspects including start-up, maintenance, and completion activities and may be responsible for coordinating studies within a business platform and overseeing other data managers working within the business platform. The primary objective of this position is to ensure clinical study data are collected, handled and validated in an appropriate and consistent manner to ensure a high quality database is delivered for statistical analysis within the agreed upon project timelines. In addition, the Principal Clinical Data Manager will be looked upon to standardize process and implement best practices in an effort to improve quality and streamline data cleaning efforts. The Principal Clinical Data Manager will demonstrate an advanced knowledge of database applications, data management processes and industry standards. He / she will perform and / or coordinate the following activities: lead initiatives to examine data management processes and evaluate new technologies, development of Case Report Forms (CRFs), development of database specifications, development of edit check specifications and the Data Management Plan, conduct data review, query generation/resolution, data coding, electronic data reconciliation and identification of protocol deviations.
Essential Job Functions:
- Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints.
- Provides leadership and technical expertise to data management staff.
- Identify gaps in current process, analyze and propose solutions.
- Establishes and maintains productive working relationships with all other functional areas that contribute to the execution of clinical studies.
- Work with business unit personnel to ensure GCD is delivering high quality and timely data management services necessary to achieve their business goals.
- Perform detailed examination and provide feedback on study protocols to ensure the data collection requirements are clear and supportive of the study endpoints.
- Accountable for the quality and timeliness of all Data Management activities from CRF design through database finalization and document archiving.
- Design high quality CRFs in consultation with a cross functional team that accurately reflect the data collection requirements identified in the study protocol and that are consistent with internal standards.
- Assist with database design to ensure it meets requirements for the entry and reporting of clinical data.
- Develop CRF Completion Guidelines to serve as an aid for site personnel to complete CRFs.
- Define Edit Check specifications and work with Database Programmers to ensure accurate and timely programming.
- Develop and maintain a Data management Plan.
- Perform user acceptance/database testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
- Conduct data review and associated query generation/resolution.
- Perform Database Finalization activities and deliver quality results within agreed upon project timelines.
- Perform data reconciliation activities as needed.
- Lead/Author SOPs, Business Guidance and/or Departmental Standards.
- Identify and understands the need for standardization and takes initiative to help improve departmental efficiency.
- Identify and implement solutions to data management issues and concerns that arise during the conduct of the study.
- Anticipates the needs of customers and takes action to ensure preparedness.
- Serve as project liaison, resolving and/or escalating as needed.
- Train GCD and/or external personnel in CDMS technology or data management process.
- Identify trends in data completion and work with CRAs and/or site personnel to help improve the quality of the data being collected.
- Maintains knowledge of current regulations and technologies related to the data management function.
- Demonstrates project management skills including the ability to manage Data Management aspects for outsourced studies.
- Demonstrates an understanding of data structures, database design constraints and needs of SAS and Clinical Database Programmers.
- May participate in supplier qualification by examining the vendor’s quality system, personnel, technology and business fit.
- Provides mentoring/coaching of new hires and/or junior associates.
- Maintains accurate and complete study records.
- Undergraduate degree required (life sciences preferred) from an accredited program or an equivalent combination of education, industry related experience, and performance may be considered.
- Minimum 6 years Clinical Data management experience.
- Minimum 5 years EDC/RDC technology experience required.
- Advanced knowledge of database application concepts.
- Advanced knowledge of data management processes and industry standards.
- Fundamental knowledge of adverse event and medication coding dictionaries.
- Experience with MS Word, Excel and PowerPoint.
- Effective communication skills both verbal and written.
- Ability to work independently with minimal supervision and accountable for managing multiple studies concurrently.
- Demonstrates leadership abilities.
- Understands clinical research process and regulatory requirements.
- Able to acquire and apply new technical skills.
- Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships.
- Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project.
- Follows through on all tasks and ensures quality results.
- Ability to Travel up to 10% of the time.
Additional Desirable Qualifications Skills and Knowledge:
- Multi-disciplinary knowledge across functional areas.
- Basic knowledge of SQL preferred to troubleshoot edit check programming and/or reports.
- Basic understanding of SAS concepts preferred.
- Knowledge of JReview preferred.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA CA - San Jose
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