Associate Clinical

Key Responsibilities

• Lead clinical studies involving healthy volunteers and patient populations, ensuring effective organization and prioritization of tasks.
• Own and be accountable for all Data Management (DM) deliverables, providing guidance to the DM team to maintain high-quality standards.
• Ensure adherence to protocols, global SOPs, and Good Clinical Practice (GCP) standards across projects.
• Collaborate with Project Managers to define study timelines and maintain communication with cross-functional leads throughout the project lifecycle.
• Provide leadership to DM project teams, coordinating internal meetings and collaborating with EDC Design, SAS Programming, and Statistics teams.
• Monitor project risks, develop mitigation strategies, and use data-driven insights to meet database lock timelines.
• Keep stakeholders informed on budget status, scope changes, and timeline impacts.
• Build and maintain strong client relationships, incorporating feedback from client satisfaction surveys to enhance service quality.
• Track and document scope changes, ensuring appropriate approvals are obtained.
• Mentor and coach internal teams on DM processes, best practices, and continuous improvement.
• Support DM managers in team performance evaluations and provide constructive feedback.
• Stay current with emerging DM technologies and industry trends to drive innovation.
• Maintain accurate records of all data management work and reconcile clinical databases with safety and lab data.
• Represent DM and Biometrics in business development activities, including audits and sponsor meetings.
• Promote Biometrics services to sponsors and perform additional responsibilities as needed.

Qualifications

Education

• University/college degree required; equivalent relevant experience may be considered in lieu of formal education.

Experience

• 6–8 years of v experience, with at least 1 year of direct sponsor/client management.
• Experience in scope management, budget tracking, and handling client concerns is preferred.
• Strong understanding of the clinical trial process, including DM, clinical operations, and biometrics.
• Proven ability to meet project timelines with excellent time management and organizational skills.
• Strong interpersonal and communication skills; ability to work collaboratively in a team environment.
• Familiarity with medical terminology.