Manager, Clinical Data Management

Ora

About The Position

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America. The Role: The Manager of Clinical Data Management oversees and manages all aspects of data management operations including staffing and resourcing, project management, budget, and operations management and client management. The manager applies a high level of technical expertise to effectively lead all data management.

Requirements

Master’s degree (preferably in Engineering, Applied or Life Science) and at least five (5) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree (preferably in Engineering, Applied or Life Science) or equivalent education and work experience with a minimum of six (6) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial.
Two (2) years of experience direct management of personnel is preferred.
Articulate and professional
Extensive experience in Clinical research
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, negotiating and resource management skills
Effective leadership, budget forecast and implementation skills
EDC experience in multiple EDC systems including Medidata Rave preferred
May Require Travel up to 10%

Nice To Haves

Clinical research in a CRO setting and CDISC SDTM training is preferred.

Responsibilities

Serve as study manager on clinical studies, as assigned, ensuring teams are delivering with quality, on time, and as per study budget
Serve as People Manager for allocated staff
Serve as subject matter expert during client and vendor meetings
Actively support business development in capabilities presentations to prospective and current clients
Effectively provide input for department and clinical study budgets
Liaise with internal and external cross-functional teams, sponsors, vendors, etc.
Mentor data management staff Ensure project work is planned, resource allocated and is successfully executed
Provide direction to staff when issues arise that the staff cannot resolve on their own
Ensure proper training and development of staff, inclusive of creation or update of Standard Operating Procedures, Work Instructions, Forms and Templates
Conduct regular meetings and completes year-end performance reviews with all direct reports
Monitor performance of team and initiate process and resource improvement in partnership with Data Management leadership
Participate in departmental initiatives, as available
Adhere to all aspects of Ora’s quality system
Comply with Ora’s data integrity & business ethics requirements
Perform other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at Ora to maintain compliance to business and regulatory requirements
Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
Responsibilities may differ from the above based on the specific needs of the business.