Manager, Clinical Data Management

POSITION TITLE: Manager, Clinical Data Management

DEPARTMENT: Data Management

Ora Values the Daily Practice of...

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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.

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
• 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.

What We Look For:

• Experience needed for the Role:
  • 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.
• Additional Skills & Attributes
  • 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%

• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well Being : Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Financial : Competitive salaries along with a 401K plan through Fidelity with company match.
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
• Career Development Opportunities :Continued opportunities to grow and develop your career journey.
• Global Team : Opportunities to work with colleagues across the globe.
• Impact : A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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