Lead Data Manager for Clinical Trials

Role Summary

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.

• Communication
• Primary communication point for project teams and company departments with regard to clinical data management
• Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
• Data Management

Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.

• Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
• Study documents review
• Data Management plan and other project-specific guidelines and instructions development and review
• Co-ordinate/perform user acceptance testing
• Development of Data Validation Plan/Edit Check Specifications
• Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues

Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data

Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)

• Database edits (paper CRF studies)
• Manual CRF review (non-medical checks)
• Clinical database lock
• Coordination and supervision of processing, dispatch and archiving of CRFs/queries
• Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
• Development of CRF completion guidelines
• Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
• SAE reconciliation
• Electronic data transfer (import/export) specifications review and approval
• Document Management
• Liaison with Document Center with regard to maintenance of TMF and eTMF
• Quality Control
• Database QC checks performance and documentation
• Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
• Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
• Training
• Training of Assistant Data Managers
• Project-specific training of investigators and clinical team in CRF completion
• Corporate/Departmental Assignments
• Investigator Meetings preparation/attendance
• Meetings and teleconferences organized by client/vendor preparation/attendance
• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
• At least 3 years of experience of full scope of data management responsibilities in international EDC studies
• At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
• Project data management experience is a plus
• Full working proficiency in English
• Organizational and managerial skills

Advance your career in clinical research and develop new skillsets whilst growing with the organization.

We’re over 2,700+ strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.

About the Company

Why Join PSI?

At PSI, we believe exceptional people deserve an exceptional workplace.

When you join PSI, you'll benefit from

A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs.

A unique leadership-focused CRA role with minimal travel and little to no routine site assignments.

Opportunities to mentor other CRAs and expand your leadership skills.

A collaborative, people-first culture where employees are genuinely supported.

Career development opportunities across a growing global organization.

The chance to contribute to innovative clinical research that improves patients' lives.

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.