Job Description

General Description:

The Senior Clinical Data Manager’s role is responsible for assigning and/or driving all aspects of the clinical trial

data management activities, from study start up through database lock, and is responsible for the quality of all

data reviewers’ deliverables.

Essential Functions of the job:

• Supports and works closely with study lead data manager(s) for assigned clinical studies.

• Performs data cleaning/reconciliation activities as specified in company procedural documents and studyspecific

Data Management (DM) documents.

• Manages queries on assigned clinical studies.

• Generates and delivers reports to study team members.

• Supports external data reconciliation, in addition to serious adverse event reconciliation.

• Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.

• Supports the creation and maintenance of DM documentation (e.g., Data Management Plans, eCRF

Completion Guidelines).

• Helps to ensure DM documents are filed per company Standard Operating Procedures (SOP) and Work

Instructions (WI).

• Supports eCRF and edit check specifications development as necessary to support data collection and

analyses required by the protocol.

• May work closely with database builders during clinical database build and programming of eCRF, edit

checks, and reports.

• Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.

• Participates in UAT activities for data transfers and programmed report outputs.

• Assists with Site and User management in clinical database of assigned clinical studies.

• May lead one or more Phase I to Phase II studies under supervision of manager.

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

escalating potential data issues to the Data Management Team when issues arise.

• May work with vendors such as central laboratories in support of timelines and data-related deliverables.

• May help identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based

on metrics data, audit reports, and input from other project team members. This also includes mentoring

other study team members when opportunities arise.

• May help train other personnel on eCRFs and EDC.

• May help support development and maintenance of SOP and WI related to data management activities.

• 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:

• 5+ 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 for ICH and regulatory environment as it pertains to data management and good

understanding of data management and phases of clinical trials

• Have a good understanding of data management knowledge and understands the phases of clinical trials

• Strong communications skills and capable of solving issues independently. • Strong project management

skills

• Excellent written, verbal and organizational skills

• Good interpersonal skills and have the capability to lead studies DR(s) and prioritize DM activities.

• 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.

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