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Manager, Clinical Data Management

Roles & Responsibilities

  • Bachelor's degree in Health Sciences, Life Sciences, Mathematics, Computer Sciences, or related discipline; Master's degree preferred.
  • Progressive clinical data management experience with proven leadership capabilities and technical expertise in CRO, Pharmaceutical, or Medical Device environments.
  • Experience with data management startup, maintenance, and closeout activities.
  • Knowledge of ICH, GCP, ISO 14155, Project Management, MedDRA, WHO Drug coding, Good Clinical Data Management Practices, and CDISC standards.

Requirements:

  • Directly supervise and lead Clinical Data Managers and Senior Clinical Data Managers, manage performance, and oversee staffing and resource allocation across multiple concurrent projects.
  • Establish operational objectives and policies; develop SOPs, Work Instructions, and departmental procedures; monitor study status to ensure GCP and company compliance; implement new systems impacting multiple projects.
  • Oversee data management activities to ensure SOP compliance, manage quality audits and regulatory submissions; ensure accurate data collection through vendor collaboration.
  • Serve as primary data management representative in cross-functional teams, partner with Clinical Operations, Biostatistics, Regulatory Affairs, and IT, and manage relationships with external vendors and CROs; contribute to protocol development.

Job description

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

Position Summary

The Manager of Clinical Data Management leads a team of Clinical Data Managers across multiple projects. This role provides direct supervision of data management staff, establishes operational objectives, and ensures data integrity and regulatory compliance in accordance with Good Clinical Data Management Practices, GCP, SOPs, and Work Instructions.

Responsibilities and Duties

Team Leadership & Management

  • Directly supervise and lead Clinical Data Managers and Senior Clinical Data Managers

  • Conduct performance management including goal setting, performance reviews, and career development for direct reports

  • Provide coaching, mentoring, and training to ensure team professional growth and operational excellence

  • Make staffing decisions and resource allocation across multiple concurrent projects

  • Serve as escalation point for team members and resolve operational conflicts

Strategic Planning & Operations

  • Establish operational objectives, policies, and procedures for data management function

  • Lead development of SOPs, Work Instructions, and departmental policies affecting multiple disciplines

  • Monitor study status across projects to ensure compliance with GCP and company procedures

  • Implement new technical systems and applications impacting multiple projects

Clinical Data Oversight & Quality

  • Oversee data management activities ensuring compliance with SOPs, Work Instructions, and guidelines

  • Manage quality audits and regulatory submission activities

  • Design and program outputs to analyze trends and patterns in complex data sets

  • Ensure accurate and complete data collection through vendor collaboration

Stakeholder Management

  • Serve as primary data management representative in cross-functional teams and stakeholder meetings

  • Partner with Clinical Operations, Biostatistics, Regulatory Affairs, and IT for integrated project delivery

  • Manage relationships with external vendors, regulatory consultants, and CRO partners

  • Contribute to protocol development and provide data management expertise

Requirements

  • Bachelor's degree in Health Sciences, Life Sciences, Mathematics, Computer Sciences, or related discipline; Master's degree preferred

  • Progressive clinical data management experience with proven leadership capabilities and technical expertise in CRO, Pharmaceutical, or Medical Device environments

  • Experience with data management startup, maintenance, and closeout activities

  • Knowledge of ICH, GCP, ISO 14155, Project Management, MedDRA, WHO Drug coding, Good Clinical Data Management Practices, and CDISC standards

  • Exposure to statistical programming packages (R, SAS, SPSS)

  • Excellent people management, communication, and organizational skills

  • Ability to manage multiple projects and lead cross-functional teams effectively

  • Expected Travel: <5% Travel Required

Salary Range: $126,720 - $144,000 (Annual Base Pay)

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. 

Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.

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