Senior/ Principal Clinical Data Manager

Fortrea•Durham, NC

9h•Remote

About The Position

Department leadership with the responsibility for ensuring successful delivery of Data Management services to clients and project teams including monitoring compliance and performance while maintaining quality. Responsibility for all aspects of the administration, management, and organization of the department and has overall responsibility for the professional and personal development for individuals within Data Management.

Requirements

University/college degree (life sciences, health sciences, information technology or related subjects preferred).
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Minimum 10 years’ relevant work experience in DM with 4 to 6 years of supervisory experience to include DM, clinical operations, and knowledge of several therapeutic areas.
Demonstrate constructive problem solving using effective communication, prioritization, and organization techniques.
Effectively operate in a continually changing environment (flexible and agile).
Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
Knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
Demonstrate skill for management of staff, both in mentoring and developing staff on technical and core competencies.
Strong managerial and interpersonal skills with the ability to motivate staff and inspire effective teamwork, especially during periods of difficulty.
Knowledge of GCPs and regulatory agency guidelines.
Advanced knowledge of or experience in clinical data management software application(s).
Additional experience may be substituted for education requirements.

Responsibilities

Ensure that the work carried out in the Data Management department is in strict accordance with relevant protocols, Standard Operating Procedures and Good Clinical Practice and that the quality of all services meets or exceeds customer requirements.
Collaborate with peers to develop and/or implement global harmonized SOPs and specific quality processes and procedures for Data Management activities.
Responsible for managing the Data Management department including managing performance and career development via the PMD process, regular catch ups and status meetings and ensuring that all group members are aware of objectives and job responsibilities.
Ensure attention is also paid to interpersonal skills and achievement of competency standards.
Review any individual issues with managers and staff proactively and in a timely fashion, work with the supervisors to resolve all issues in a supportive manner, creating and maintaining performance plans, as appropriate.
Provide constructive feedback as appropriate.
Collaborate with peers to establish global Data Management competency models and assist with the development of training programs and ensure staff achievement of position competencies.
Support Data Managers to ensure that studies are delivered according to Sponsor requirements on time, to high quality and within budget.
Manage all project team members effectively providing training, acting as source of advice and performing oversight as appropriate.
Responsible for contributing to departmental recruitment and hiring decisions.
Determine required staffing levels to meet short-term and long-term department needs, liaising with senior management as appropriate.
Ensure that all new hires are assigned objectives and receive applicable training.
Contribute to development of department strategies and objectives that align with company-wide goals and targets.
Review and approve department metrics for input into financial costing models.
Ensure that these are kept up to date and that Business Development is aware of any updates.
Responsible for reviewing and providing input into the Data Management budget, monitoring resource allocation, revenue and direct costs.
Ensure that department financial targets and business requirements including expected margins are met.
Work with peers and senior management to establish global Data Management processes and initiate and/or implement process improvements to increase efficiency and to ensure standards are applied consistently.
Actively support business development activities including participation in Bid Defenses, Request for Proposals (RFPs) and Request for Information (RFIs).
Work closely with our Business Development representatives in maximizing new or existing business opportunities.
Establish and maintain strategic client relationships, managing issues and escalations efficiently and effectively, and implement appropriate action plans to address client feedback (i.e., customer survey results) as necessary.
Participate in client, internal or agency audits and inspections.
All other duties as needed or assigned.
The position has full responsibility for managing staff. This includes hiring, coaching, resource management, assigning /delegating work, conducting performance reviews and determining pay/promotions.
8-10 Direct Reports
10-80 Indirect Reports