Director, Clinical Data Management

POSITION TITLE:

Director, 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:

Oversees and manages all aspects of data management operations including staffing and staff development, project resource planning/loading, project management, leading/supporting implementation of strategies to improve efficiencies, sponsor support, and assuring quality work execution and output.  Actively participates in business development and strategic planning.  Applies a high level of technical expertise and professional experience to effectively lead data management and clinical programming staff and to develop solution

alternatives to problems.  Keeps Leadership apprised of data management project status.  Maintains performance metrics that are adequately analyzed for trends, root cause(s) and corrective action(s).

What You’ll Do:

• Oversee day-to-day data management operations.
• Provide leadership to allocated team guiding overall operations and management of resources to allow for growth of Ora clinical data management and individual team members
• Serve as CDM subject matter expert in cross-functional initiatives and perform expert level customer communication and collaboration activities.
• Support business development in capabilities presentations to prospective and current clients.
• Manage department and clinical study budgets to achieve or beat targets.
• Liaise with internal and external cross-functional teams, sponsors, vendors, etc.
• Participate in proposal and contract writing and negotiation.
• Review/write/update standard operating procedures, work instructions, forms and templates, ensuring maximum efficiency in CDM processes.
• Strive to continuously improve data management operations to reduce cost and timelines, while improving quality.
• Manage resourcing and workload of CDM team.
• Develop, maintain, analyze and report on departmental performance metrics and KPIs.
• Develop and conduct in-house training and development.
• Adhere to all aspects of Ora’s quality management system.
• 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: Bachelor’s degree in applied or life science and minimum of twelve (12) years of experience in clinical trials, with at least ten (10) years in data management, or equivalent education and work experience.
• Advanced degree and direct supervisory experience preferred.
• Additional Skills and Attributes: Extensive experience in clinical data management preferably within a CRO environment.
• Successful leader with a record of accomplishment in establishing, directing and overseeing data management operations division/department in a dynamic environment, including budgeting and forecasting, individual and team leadership, as well as process and project management.
• Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11.
• CDISC CDASH/SDTM training and experience.
• Experience in ophthalmology is a plus.
• Skills including programming and medical coding (adverse events, medical history and medical therapies) are a plus.
• EDC experience (Oracle Clinical Life Sciences Suite and iMedNet) is a plus.

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.

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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