[Hiring] Manager, Clinical Data Management @Ora

Role Description

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.

What You’ll Do:

• 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.
• 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.

Qualifications

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

Requirements

• 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%.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Providing you the freedom to unwind and recharge with Flexible PTO & Unlimited Sick Time in addition to 14 company paid holidays.
• Competitive salaries along with a 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Offering peace of mind with Company Paid Life & Disability Insurance.
• Remote & Wellness Reimbursement to support your remote workspace and wellness purchases.
• Employee Assistance Program for support with various issues.
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.