Job Description

Position Summary:

The Data Manager is a key member of the Development Operations, Data Management Team.  Data Managers serve as a key member of project teams, responsible for managing all data management tasks from project start-up to database lock, to produce a clean and analyzable database.

Position Responsibilities/

Accountabilities:

-Manages Data Management project activities:

·         DM lead for internal/client team meetings and communication.

·         Produces and reviews metric reports for internal/external project team.

·         Ownership of project deliverables within DM scope of services

·         Discusses roadblocks and solutions for completing project objectives in a timely manner.

·         Assists in reviewing project budgets and staffing projections for data management activities.

·         Provides training of other DM staff on project specific processes.

·         Ensures adherence to GCP, regulatory guidelines and standard operating procedures

·         Manages database lock, transfer and CRF archiving for assigned projects.

·         Manages client relationships

-Clinical Data and Query Review:

·         Creates the Data Quality Review Plan and coordinates input from cross-functional team members

·         Defines the DM listings using ad hoc query tools.

·         Reviews clinical and external vendor data to ensure a high degree of quality.

·         Issues queries and reviews query responses based upon the Data Review Specifications, Aggregate Checks (DM listings), Reconciliations (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports.

·         Coordinates medical coding activities.

·         Monitors data quality and integrity, ensuring compliance with company and regulatory standards

• May participate at bid defense meetings and sponsor presentations.

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-Oversees System Development and Modifications:

·         Drafts the CRF design specification, edit check specification and DM listings.

·         Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc.)

·         Consolidates comments from internal team/sponsor for discussion and approval.

·         Ensures all non-DM activities related to database development are completed in a timely manner.

·         Manages all database modifications for DM activities.

-Validation Creation:

·         Assists with and/or performs the validation of CRF system (CRF content & edit checks), reports using EDC Reporting and/or J- Review, and associated change control requests.

-Creates and maintains documentation for the project:

·         Develops study-specific Data Management Plan along with supporting DM documents, such as CRF Completion Guidelines, Data Entry Guidelines, Trial Design Document, Edit Specifications, Reconciliation Guidelines, and Report Specifications.

·         Provides and/or maintains relevant data management documentation for filing in the Trial Master File.

Managerial Requirements/ Responsibilities:

N/A

Position Qualification Requirements:

Education: Bachelor’s degree in one of the life sciences, or equivalent knowledge and experience.

Experience:

·         Five to Seven years of clinical data management experience in pharmaceutical industry and/or contract research organization.

·         Experience as a Lead Data Manager, Oncology and Hepatology trial experience preferred.

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Required Certifications: N/A

Required Skills:

·         Team player with ability to learn new things and mentor others.

·         Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Bios, etc.) and maintain positive and open relations with internal, sponsor, and vendor team members.

·         Ability to facilitate team meetings.

·         Knowledge of clinical trials concepts.

·         Ability to create detailed DM project instructions and documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.)

·         Proficiency with data processing systems (EDC systems, preferably Medidata RAVE,

·         Proficiency with Catalyst SOPs, WPs for general and DM operations.

·         Good understanding of Good Clinical Practices and relevant regulatory guidelines.

·         Familiarity with CDISC standards.

·         Efficient with organizational skills to meet deadlines.

·         Organized and thorough with attention to details.

·         Effective interpersonal skills and excellent communication skills, verbal, written and listening.

·         Ability to accept constructive criticism.

·         Effective logical thinking ability regarding problem-solving skills.

·         Proficiency in computer applications and time management tools (Excel, Word, Outlook, Project, etc.)

·         Ability to travel frequently for meetings or training activities may be required.

Physical Demands (US ONLY):

Sedentary work that primarily involves sitting/standing

Acknowledgement:

My signature below acknowledges that I have read the above job description and agree that I can perform the responsibilities and meet the requirements as presented. I understand this job description provides a general outline of job responsibilities and requirements and is not intended to be all-inclusive. I also understand that job responsibilities and requirements may change at any given time based on organizational or departmental needs.

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