Senior Clinical Data Manager

Position Summary: The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.

Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing

May perform quality control of data entry

Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.

Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders

May assist in building clinical databases

Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.

May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications

Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.

Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.

Review and query clinical trial data according to the Data Management Plan

Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM

Run patient and study level status and metric reporting

Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency

Coordinate SAE/AE reconciliation

Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables

May assist with SAS programming and quality control of SAS programs used in the Data Management department

Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project

Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities

May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings

May review Request for Proposals (RFP), proposals, provide project estimates

Provide leadership for cross-functional and organization-wide initiatives, where applicable

Trains and ensures that all data management project team members have been sufficiently trained

Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

May present software demonstrations/trainings, department/company training sessions, present at project meetings

May require some travel

Perform other duties as assigned

Qualifications: Minimum Required:

Bachelors and/or a combination of related experience

Other Required:

10+ years’ experience

Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook

Able to handle a variety of clinical research tasks

Excellent organizational and communication skills

Professional use of the English language; both written and oral

Experience in utilizing various clinical database management systems

Broad knowledge of drug, device and/or biologic development and effective data management practices

Strong representational skills, ability to communicate effectively orally and in writing

Strong leadership and interpersonal skills

Ability to undertake occasional travel

Preferred:

Experience in a clinical, scientific or healthcare discipline

Dictionary medical coding (MedDRA and WHODrug)

Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)

Oncology and/or Orphan Drug therapeutic experience

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