Summary:

Responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock

Lead data review activities and engage different functional groups leading to active participation in ensuring data integrity and completeness

Contribution to the definition of defined company data standards and conventions

Functioning as an advisor for Clinical Data Management activities to all project teams

Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices

May contribute to department and other project budget planning

May be required to support inspection readiness activities, as well as participate in sponsor and site inspections

Key Duties/Responsibilities

Participate in protocol review and CRF design (paper or eCRF)

Write edit check specifications and test edit checks

Perform user acceptance testing on database applications and data transfers

Generate, process, track and resolve queries

Prepare Data Management Plans

Perform SAE reconciliation between the clinical database and the Drug Safety database

Perform external data reconciliation

Close study database based on predefined criteria as per timelines

Assist in defining and the follow-up of milestones and timelines

Lead various data management meetings for CRF development, e-Help, edit checks with study team

Train sites at investigator meetings and data management staff on study database

Provide support to data management staff over the course of the study

Represent Data Management as the lead contact and liaison on the clinical study team

Responsible for the role which includes the management and maintenance of clinical data and interfacing with clinical teams

Provides leadership and content expertise for Clinical Data Management activities from start up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities

Member of the Protocol Review Team, CRF Review Team, Medical Safety Monitoring Plan Reviewer, member of the Clinical Study Report Review Team, and may perform peer review of Clinical Data Management deliverables as a Peer Data Management Lead

Key contact for Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non Translational Sciences (NTS)

Participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.); involvement in assessment/re assessment of vendor capabilities, as necessary

Key contact for R&D Sourcing and Clinical Vendor Oversight (CVO)

The implementation of quality, efficient, and consistent approaches to carrying out Clinical Data Management tasks

Minimum Requirements:

Bachelor s Degree with 5+ years of Clinical Data Management experience

Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting)

Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials

Strong knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.)

Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization

Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment

Demonstrates a solution oriented approach to problem solving and a can do attitude