Director, Clinical Data Management

Ora, Remote - US +1

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.

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Director, Clinical Data Management

Ora, Remote - US +1

Posted pay

Pay not posted

Location: Remote - US +1
Work type: Remote
Level: Director+, manager
Experience: 12+ years
Posted: 25 days ago
Last check: 3 h ago
Job type: Software engineering

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About Ora: funding, hiring and pay

Ora

About Ora: funding, hiring and pay

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The role

What you need

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.

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Director, Clinical Data Management

The role

Director, Clinical Data Management

The role

What you will do

What you need

Ora Values the Daily Practice of

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