Project Data Manager

General Description:

Project Data Management role is responsible for all aspects of the clinical trial data

management process from study start up through database lock and support of clinical study

report (CSR) activities for assigned studies. This role is also accountable for quality of

deliverables and resource efficiency of assigned studies. This role may be expected to lead

multiple clinical studies and/or oversee CRO/FSP vendors for multiple clinical studies.

Essential Functions of the Job:

• Lead studies within a program

• Oversee data managers working on studies either in-house or CRO/FSP resources

• Serves as active member of Clinical Study Teams.

• Collaborates with other functions to develop timelines and ensure that clinical data

management deadlines

• are met.

• Defines external data transfer specifications and works with external vendors in support

of timelines and data

• related deliverables.

• Ensures process is in place to review and reconcile lab data with lab normal ranges

• Develops or oversees development of eCRF and edit check specifications as necessary

to support data

• collection and analyses required by the protocol.

• Works closely with database builders during programming of EDC databases, edit

checks and reports.

• Drives and performs User Acceptance Testing (UAT) activities for clinical trial database

build and

• modifications.

• Develops or oversees development of study-specific eCRF Completion Guidelines and

Data Management

• Plans

• Creates and maintains data management documentation.

• Ensure data cleaning activities as specified in the Data Validation Specifications and

Data Management Plan.

• Works with coding group to ensure coding is applied to assigned clinical studies in

conjunction with study

• timelines and deliverables.

• Defines listings in support of data management, clinical and medical review of data.

• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for

studies based on

• metrics data, audit reports, and input from other project team members.

• Will have the opportunity to drive all data review related activities. This will also include

identifying and

• escalating potential data issues to LDM when issues arise.

• Trains other personnel on eCRFs and EDC, as needed.

• Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.

• Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and

other documents as

• required.

• Support management team with continued process improvement/innovation for the

department and

• participates in the development and maintenance of Standard Operating Procedures

(SOPs) and Work

• Instructions related to data management activities.

• Will oversees data managers working on studies either in-house or CRO/FSP resources

to ensure studying

• the support on the studies are sufficient.

• Collaborates with program lead and other functions to ensure program-consistent, highquality

and on-time

• data delivery.

• May mentor other junior Clinical Data Managers.

• Other duties as assigned.

Supervisory Responsibilities:

NA

Computer Skills:

• Proficient computer skills, including Microsoft Office applications

• Working knowledge of at least one EDC system, Medidata Rave is preferred

Other Qualifications:

• 6+ years of experience in clinical data management in the

pharmaceutical/biotechnology industry

• Oncology experience preferred

• Ability to work in cross-functional team-oriented environments

• Understanding of ICH and regulatory environment as it pertains to data

management

• Experience with SDTM/CDASH

• Strong project management skills

• Excellent written, verbal and organizational skills

• Must be detail-oriented

Travel:

Travel may be required as per business need, ability to travel domestically and

internationally.

Education Required:

Bachelor’s degree or

equivalent in a health-related

field preferred

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.