Job Category: Pharmaceutical & Biotech

Mgr, Clinical Data Management (DG)

Job Location: N/A, NJ (see all jobs in NJ)

Work Type: Remote

Date Posted: 2022-06-21

Manager, Clinical Data Management
NJ - Remote

The Manager, Clinical Data Management is responsible for leading and overseeing all data management activities for research studies in compliance with departmental SOPs and all regulatory guidelines. The Manager, Clinical Data Management works as an integral part of a cross-functional team throughout the lifecycle of the research study from design through final analysis and study closeout by collaborating with the project teams and providing oversight and direction, data review, analytics, and reports. This position will ensure the clinical study data is collected, handled, and validated in an appropriate and consistent manner to ensure high quality data is delivered to support the statistical analysis.

The Manager, Clinical Data Management will be looked upon to evaluate and implement efficiencies to improve the performance of the Data Management team such as evaluating technologies, resourcing, standardizing processes, CRF design, data collection, data validation, analytics, and reporting. In order to support this, the Manager, Clinical Data Management will demonstrate advanced knowledge in people management, clinical database systems, tools, applications, processes, and industry standards. This role will provide oversight and direction to data management staff across therapeutic areas, programs, and projects.

The Manager, Clinical Data Management is responsible for executing, overseeing, and synchronizing the following activities: ensuring appropriate data management support across programs and projects, leading and coordinating initiatives to evaluate and implement efficiencies, review of Data Management documentation and deliverables, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, and maintenance of study documentation in the electronic Trial Master File (eTMF).

Job Details:
Responsibilities include the following and other duties may be assigned: Provide direction, leadership, mentoring, and coaching to data management team members. Provide insight to the development of direct reports and the data management function. Provide input and oversight on data management resourcing and planning. Review and provide input to data management documents and deliverables. Identify efficiencies and gaps in current process, perform analysis, propose and implement solutions. Lead and author data management and cross-functional processes, standards, and tools. Anticipate the needs of internal and external partners and take the appropriate actions to ensure preparedness. Identify, escalate, and resolve departmental, program, and project related issues. Leverage project management skills including the ability to support and oversee multiple projects both insourced and outsourced. Participate in vendor and/or supplier qualifications for business fit. Review and provide detailed input to study protocols ensuring data collection requirements are logical, consistent, and supportive of study endpoints. Establish and maintain conducive relationships with cross functional partners to ensure the execution of research studies. Partner with therapeutic area personnel to ensure timely and high-quality Data Management deliverables are delivered in support of business goals. Accountable and responsible to ensure the delivery of high-quality Data Management deliverables and activities from protocol review through database closure and archiving. Design high quality CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints. Develop and define edit check specifications. Ensure the database design meets the requirements for data entry and reporting as per the specifications. Develop and maintain the Data Management Plan throughout the life of the study. Communicate and provide guidance with study team members and sites on outstanding items. Develop the Completion Guidelines to aid the site personnel to complete the CRFs. Perform User Acceptance Testing to ensure the quality and integrity of the clinical study database design, associated edit checks, and programming prior to the database being released to collect data. Identify data trends and work with study personnel to ensure high quality data is being collected. Identify, document, and implement solutions to data management issues in conjunction with the DM and cross-functional teams. Generate and provide study reports to the applicable study team members as appropriate. Assist the CRAs with preparation for monitoring visits such as running reports and providing metrics. Perform data review and query generation & resolution including third party data reconciliation to ensure the delivery of high-quality data. Maintains complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines. Prepare reports of clinical studies for internal validation and cross validation studies. Train internal and external personnel in the CDMS system(s), technology, applications, and Data Management process. Attend, participate, and lead departmental, functional group, program, and project meetings as required. Perform routine audits of study files and records to ensure compliance with standards.

Knowledge, Skills and Abilities (KSAs):
Demonstrates an advanced understanding of database design, data structure, design constraints & cross-functional needs to support clinical trials. Understand the need for standardization & implement solutions to improve efficiencies. Demonstrates excellent leadership capabilities. Advanced knowledge of adverse events & medical coding such as MedDRA. Highly organized with the ability to prioritize and manage multiple activities concurrently. Advanced working knowledge of the clinical research process and regulatory requirements. Advanced knowledge of data management processes and industry standards. Ability to work independently with minimal supervision. Ability to establish positive working relationships and rapport with both internal and external team members. Ability to anticipate and identify data trends, issues, problems and delays and escalate and resolve them appropriately to minimize their impact. Advanced knowledge and experience with Electronic Data Capturing Systems (e.g., Medidata RAVE, ORACLE Clinical, Veeva, OpenClinica, iMedNet, Medrio, etc.) required. Advanced knowledge/experience with clinical data reporting tools such as JReview. Knowledge of and skill in using Microsoft Office suite (e.g., Visio, PowerPoint, Word, Excel, OneNote, Outlook, TEAMS, etc.). Advanced understanding of ICH, ISO, GCP, & GDP guidelines. Advanced project management, analytical and problem-solving skills. Excellent interpersonal, verbal, & written communication skills and be able to effectively work across departments with diverse needs. Excellent organizational/time management skills. Ability to work within a cross-functional team through the various stages of the product development process. Ability to work in a highly matrixed team environment. Ability to adapt to changing priorities. Knowledge of SQL preferred. Understanding of SAS concepts preferred.

Background Experiences:
Bachelor’s degree in a Math, Computer Science, Life Sciences field required or equivalent combination of education, training & industry related experience; advanced degree strongly preferred. Previous experience with direct people management is highly preferred. 10 + experience required supporting clinical research studies within a data management, data analytics, or data reporting function.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

Up to 165K base, 20% bonus

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