Associate Clinical Data Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee clinical data management projects from initiation to database locking.

• Create project documentation, set up systems, and establish procedures for data entry and validation.

• Manage all deliverables related to data management, including timelines, budgets, and resource allocation.

• Offer guidance, leadership, mentorship, and coaching to data management study teams.

• Ensure adherence to protocols, globally harmonized standard operating procedures (SOPs), and Good Clinical Practice (GCP) standards.

• Collaborate with Project Managers to develop timelines and coordinate deliverables across EDC Design, SAS Programming, Statistics, and Pharmacokinetics (PK).

• Facilitate data-centric internal project meetings and identify potential risks and mitigation strategies.

• Keep Project Managers, Biometrics management, and sponsor services updated on project status, budget, scope, and timeline implications.

• Cultivate and maintain client relationships while reviewing client satisfaction surveys.

• Monitor scope changes and secure Sponsor approval in conjunction with the Project Manager.

• Reconcile clinical databases with safety, laboratory, and other external data sources.

• Utilize local laboratory systems and batch data loading capabilities.

• Represent Data Management and Biometrics in new business ventures.

• Participate in and address client or internal audits and resolve any arising issues.

• Respond to client feedback and advocate for Biometrics services to sponsors.

⛳️ Requirements

• A university or college degree; relevant experience may be accepted in lieu of educational qualifications.

• Experience or education along with relevant work experience that equates to a bachelor's degree may be considered instead of a formal degree.

• Proficient in English, both written and spoken.

• 6 to 8 years of experience in Data Management.

• At least 1 year of direct experience in sponsor management.

• Understanding of clinical trial processes, Data Management, clinical operations, Biometrics, and associated system applications.

• Preference for candidates with the ability to manage customer concerns, Scope of Work, and budgets.

• Strong time management skills with the ability to meet project productivity metrics and timelines.

• Capability to work collaboratively in a team environment and engage with colleagues.

• Excellent organizational, communication, interpersonal, and teamwork skills.

• Familiarity with medical terminology.

• A university or college degree in life sciences, health sciences, information technology, or related fields is preferred.

• A scientific background is preferred.

• In-depth knowledge of Fortrea, its organizational structure, and SOPs.

• At least 3 years of experience in Electronic Data Capture.

• Willingness to work overtime and weekends as needed.

• Flexibility to work shifts based on business requirements.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(K) plan.

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

• Company bonus, where applicable.

• Flexible shifts based on business needs.