Theradex Systems, inc.
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Manager, Data Management
at Theradex Systems, inc.
Princeton, New Jersey
# of Openings:
We are seeking a Manager, Data Management for our Princeton, NJ headquarters.
What’s in it for you?
Theradex supports many of the most prominent pharmaceutical and biotech companies in the industry with promising new molecules addressing a wide range of oncology indications. We provide a supportive environment and through our expertise, innovative systems and processes, we give you the tools to be successful as we grow our commercial team.
What you'll do:
- Assist in leading and overseeing data management, EDC programming and validation team in the U.S. and U.K. offices involved in industry and government supported trials with emphasis on the data management teamCoach, develop and provide continuous feedback to team members - Provide guidance and direction to ensure departmental and both client/project goals are met
- Serve as liaison to internal and external clients, ensures effective resource allocation
- Develop and track metrics on productivity and quality and creates strategies and best practices to increase efficiency
- Responsible for overseeing all DM activities leading up to and including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff:project management, medical writing, biostatistics and programming
- This includes the lab norms and deviations processesEnsures that standards are applied across studies (EDC Builds, CRFs, CRF Completion Manuals, Edit Checks, etc)
- Assists in managing the development and validation of IWRS and EDC study builds and the associated data listings, reports, data transfers and detailed timelines
- Monitors data management workflow and tracks project metrics for task completionDefines CRF standards, oversees individual study CRF design and production
- Responsible for the development and approval of standard edit checks and study specific edit checks
- Oversee the review of clinical trial data to identify erroneous, missing incomplete, or implausible dataReview protocol compliance
- Approve Data Management Plans and CRF Completion Manuals
- Partnered responsibility for process documentation and training curriculum
- Assist in developing, revising and reviewing SOPs and WPDs and develop associated training and competency testing
- Interact with dictionary coding personnel to ensure appropriate process set-up and application
- Lead weekly l status meetingsEffectively allocate resources and lead efforts to agree on solutions
- Ensure that the team adheres to SOPs and GCP regulationsThis position requires a limited amount of travel, less than 10%.
Experience and qualifications needed:
- Bachelor’s degree, preferably in a science - related field. Master’s degree preferred
- Prior relevant leadership experience inclusive of the following proficiencies
- Managing direct reports and high performing teams Clinical Data Management preferably with oncology experience and understanding of clinical data reporting processes and content
- Oracle Clinical / Inform/ and/or Rave -Remote Data Capture (OC/RDC) experience as well as relational database and report development experience, including basic SQL knowledge
- Proficiency with web-based EDC systems / Medidata Rave EDC experience required
- Experience with IWRS systems preferred
- Familiarity with data reporting requirements for oncology clinical trials preferred
Skills and Competencies to be Demonstrated:
- Strong leadership skills driving change and process by example Strategic and critical thinking skills
- Demonstrates ability to build and maintain effective relationships with others, establishing collaborative partnerships, trust and shared purpose
- Results-oriented; effective ability to set and meet short-term and long-term goals
- Strong communication, organization and decision-making skills
- High level of agility and diplomacy
- Effective ability to handle matters objectively
- Must be able to anticipate challenges and project risks and proactively implement solutions
- Strong time management and effective planning skills
- Strong working knowledge of MS Office and Outlook
- Knowledge and understanding of regulatory guideline for use of computer systems in clinical studies
- Demonstrated knowledge of GCPs, ICH guidelines, CFR Part 11 and computer systems validation
What we offer: We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, 401(k), tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
Disclaimer: This job description is intended to describe the general nature and level of the work to be performed and requirements needed for this role. It is not intended to include every job duty and responsibility specific to the position.
Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Search Firm Representatives: Theradex is not accepting assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Theradex via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Theradex. No fee will be paid in the event the candidate is hired by Theradex as a result of the referral or through other means.
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