Senior Clinical Data Manager

About the job

Job Title: Senior Manager, Clinical Data Management

Department: Clinical Data Management

Location: Remote, with occasional travel

Reports To: Director, Clinical Data Management

FLSA Status: Exempt

Job Type: Full-Time; Must be legally authorized to work in the US

Position Summary:

The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech/pharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials.

The Senior Manager, Clinical Data Management, is responsible for oversight of data management operations for assigned clinical research trials managed by GCAR. The Senior Manager may serve as a back-up for the Director when needed. The Senior Manager is responsible for the guidance, development, and oversight of assigned team members, which may include Specialists, Senior Specialists, Associate Managers, and Managers. This role reports to the Director, Clinical Data Management.

The Senior Manager is responsible for the oversight, review, and monitoring of clinical study data to ensure data quality and completeness. Knowledge of the International Conference on Harmonization Guideline for Good Clinical Practice (ICH GCP), U.S. Federal Regulations, and applicable regional requirements is critical.

The Senior Manager interfaces with internal and external stakeholders across several functions, including Regulatory, Clinical Operations, Data Management, and Statistics, as well as biopharma partners, external physicians, research staff, CROs, and other vendors. Where appropriate, the Senior Manager will attend seminars, investigator meetings, project meetings, and educational conferences or training sessions. The individual is expected to represent GCAR professionally, demonstrate strong business ethics and integrity, and establish and maintain strong relationships with all stakeholders (Investigators, Advisors, study personnel, and vendors).

This role is remote (work-from-home) but may involve occasional domestic and international travel.

Key Responsibilities:

• Oversight of clinical study data collection for all assigned clinical studies

• Recruitment, supervision, training, and performance development of assigned team members

• Management and updates of unblinded/confidential data access plans

• Oversight of clinical data management processes in alignment with biostatistical objectives, including active participation in biostatistics meetings

• Generating and/or reviewing study documents (e.g., Data Management Plans, Data Dictionaries, Data Review documentation, DM/Trial Master File documents, study protocols, etc.)

• Accountability for on-time and within-budget execution of data management activities for assigned projects

• Escalating concerns regarding timelines, milestones, resourcing, budget impact, and potential study execution issues to appropriate internal stakeholders

• Reviewing data and preparing materials for internal or external meetings

• Assisting with presentations to internal and external stakeholders

• Writing and/or reviewing standard operating procedures and work instructions for data management activities

• Managing data-management and clinical-operations database systems for assigned clinical studies

• Ensuring audit and inspection readiness regarding clinical data management of assigned clinical studies

• Serving as a key contributor to CRO/vendor selection and management for clinical data management activities

Qualifications:

BS degree in bioinformatics, life sciences, or a related health field preferred

8–10 years of direct experience in data management preferred

Ability to attend meetings and support trial activities outside local office hours as needed

Must be legally authorized to work in the United States.

Skills:

Advanced-level Excel skills

Prior experience in Data Management, including oversight of Electronic Data Capture (EDC) systems (Medidata RAVE preferred), Interactive Response Technology (IRT) systems, and data completeness and accuracy

Experience with clinical data management database systems

Comprehensive understanding of the clinical trials process, the application of SOPs, and medical terminology

Prior experience across all phases of clinical trials

Prior Quality Control experience

Knowledge and understanding of GCP and GCDMP

Strong strategic, analytical, and critical-thinking skills to evaluate complex issues from multiple perspectives (macro and micro) and drive informed decision-making

Strong planning and organizational skills, with high attention to detail and flexibility in a dynamic environment, with experience leading projects with competing deadlines

Excellent interpersonal skills, complemented by outstanding verbal and written communication skills, and demonstrated flexibility, adaptability, resourcefulness, and creativity

Ability to work independently and efficiently while maintaining strong and collaborative working relationships

General Information:

The information above is intended to describe the general nature and level of work performed by an individual assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, or skills required. The individual in this role must be able to work in a fast-paced, deadline-driven environment with the ability to prioritize multiple, competing tasks and to seek leadership assistance as appropriate.