Manager, Clinical Data Management

Ora

About The Position

The Manager of Clinical Data Management oversees data management operations, including staffing and resourcing, project management, budgets, operations, and client management. The role applies technical expertise to lead data management activities and may serve as study manager on clinical studies, ensuring teams deliver quality work on time and within budget. The manager also serves as a people manager and subject matter expert, supports business development, and works with internal and external cross-functional teams, sponsors, and vendors. Responsibilities may vary based on business needs. Ora is a full-service ophthalmic drug and device development firm supporting clinical research across all phases. The company has more than 600 employees across North America, Europe, Asia, and Latin America and has supported more than 85 new product approvals over 45 years. Ora emphasizes kindness, operational excellence, joy, and scientific rigor, and describes its work as supporting innovation in ophthalmology and improving patient outcomes. The position may require travel up to 10%. Ora offers a range of benefits to eligible full-time employees working at least 30 hours per week.

Requirements

Master’s degree, preferably in Engineering, Applied Science, or Life Science, and at least five years of Clinical Data Management experience, including leading several clinical studies; or a Bachelor’s degree, preferably in Engineering, Applied Science, or Life Science, or equivalent education and work experience, with at least six years of clinical trials experience; or current Certified Clinical Data Manager (CCDM) status and six years of clinical trial experience.
At least two years of direct personnel management experience.
Extensive clinical research experience.
Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
Strong project management abilities, including analytical evaluation, organization, delegation, flexible team management, negotiation, and resource management.
Effective leadership, budget forecasting, and implementation skills.
Articulate and professional communication.
May require travel up to 10%.

Nice To Haves

Clinical research experience in a CRO setting.
CDISC SDTM training.
Experience with multiple EDC systems, including Medidata Rave.

Responsibilities

Serve as study manager on assigned clinical studies, ensuring teams deliver quality work on time and within the study budget.
Manage allocated staff and mentor data management personnel.
Serve as a subject matter expert during client and vendor meetings.
Support business development through capabilities presentations to prospective and current clients.
Provide input for departmental and clinical study budgets.
Liaise with internal and external cross-functional teams, sponsors, vendors, and other stakeholders.
Ensure project work is planned, appropriately resourced, and successfully executed.
Provide direction to staff when they encounter issues they cannot resolve independently.
Ensure staff training and development, including creation or updating of Standard Operating Procedures, Work Instructions, Forms, and Templates.
Conduct regular meetings and complete year-end performance reviews with direct reports.
Monitor team performance and partner with Data Management leadership on process and resource improvements.
Participate in departmental initiatives as available.
Adhere to Ora’s quality system, data integrity and business ethics requirements, and systems and processes for regulatory and business compliance.
Demonstrate Ora’s values and associated behaviors.
Perform other related duties incidental to the work described.