Senior Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee clinical data management studies from the initiation phase to database lock.

• Assume responsibility for project documentation, system configuration, data entry, and data validation processes.

• Serve as a subject matter expert for data management activities during Sponsor relationship meetings.

• Comprehend Sponsor requirements and spearhead their execution.

• Offer guidance, mentorship, coaching, and training to data management personnel.

• Manage data management deliverables, study team directives, output assessments, and resource distribution.

• Ensure adherence to protocols, global harmonized SOPs, and GCP standards across projects.

• Collaborate with Project Managers or FSP Leads to develop timelines that meet contracted milestones.

• Facilitate internal project team meetings focused on data and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams.

• Identify risks and mitigation strategies, communicate data-driven insights, and support database lock timelines.

• Keep project, Biometrics management, and Sponsor services teams updated on project progress, budget status, scope modifications, and timeline effects.

• Oversee the receipt and inventory of clinical site and vendor data.

• Cultivate client relationships, review client satisfaction surveys, and implement action plans for process enhancements.

• Monitor scope changes and secure Sponsor approval.

• Provide technical insights into strategy, SOPs, training, and mentorship.

• Reconcile clinical databases with safety, laboratory, and third-party data.

• Utilize local laboratory systems and batch data loading capabilities.

• Represent Data Management in new business ventures and bid defense opportunities.

• Attend to and resolve client or internal audit matters.

• Maintain precise work records and perform additional duties as assigned by management.

⛳️ Requirements

• Bachelor’s degree from a university or college; relevant work experience and/or education equivalent to a bachelor's degree may be considered in lieu.

• Fortrea may evaluate relevant and equivalent experience in place of educational qualifications.

• A minimum of 8 years of combined experience in early- or late-stage data management.

• At least 2 years of direct Sponsor management experience.

• A minimum of 2 years of experience in technical mentoring.

• Proven experience in customer negotiations and managing Scope of Work and budgets.

• Comprehensive knowledge of clinical trial processes, data management, clinical operations, Biometrics, and related system applications.

• Capability to lead project strategies and fulfill departmental goals, objectives, and initiatives.

• Familiarity with CRO industry relationships and regulatory obligations related to pharmaceutical/biotechnological companies.

• Strong time management skills with the ability to meet productivity targets and deadlines.

• Ability to collaborate effectively within a team environment.

• Competence in mentoring junior department members and providing SME guidance on data management practices.

• Experience representing Data Management in bid defense meetings.

• Excellent organizational, communication, and interpersonal skills.

• A constructive problem-solving approach and the ability to work under deadlines, time constraints, incomplete information, or unexpected situations.

• Proficiency in English, both spoken and written.

• Preferred: a degree in life sciences, health sciences, information technology, or a related field.

• Preferred: four or more years of experience with Electronic Data Capture.

• Preferred: knowledge of the Fortrea organization and its SOPs.

• Potential travel for cross-site support or training, with meetings up to 10% of the time.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Life insurance

• STD/LTD insurance

• 401(K)

• Paid time off (PTO) or Flexible time off (FTO)

• Company bonus where applicable