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Director, Clinical Data Management

Boston, MA

Nimbus has an outstanding opportunity for a Director of Clinical Data Management to join our team.  In this position, you will be responsible for all study-specific data management execution at the study level (protocol review, database build, migrations, and locks, monitoring of outsourced data activities, etc.) and oversee data management activities across the company.  This individual will collaborate with internal and external teams / vendors and play a key role in ensuring the accuracy, integrity, and efficiency of clinical trial data, with a particular focus on Oncology trials.

In This Role, You Will:

  • Serve as the clinical data management lead within the company and at the study level, managing all aspects of data management from study start-up to database lock to ensure data is collected, reviewed, and delivered efficiently
  • Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and internal data reviews
  • Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other relevant study documentation
  • Provide data management expertise and support to the Clinical Development Team, contributing to the overall strategic direction and execution of clinical trials
  • Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct and oversee data reviews
  • Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
  • Develop and implement departmental workflows and infrastructure including SOPs, work instructions and templates to reflect industry best practices and adherence to regulatory requirements
  • Manage internal and external resources effectively to ensure the success of studies and overall business objectives
  • Provide ongoing operational support for Medidata RAVE activities during clinical trial conduct including the development of clinical databases and associated external data transfer documents including import/export agreements and data specifications
  • Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution
  • Contribute to the development and execution of corporate initiatives, specific Business Development activities, and various organizational initiatives within Clinical Development

These Qualifications Will Help This Role Be Successful:

  • Bachelor’s degree in life science or health-related field.  Advanced degree preferred
  • 12+ years industry experience within clinical data management, including proven experience managing Oncology clinical trials
  • Experienced in vendor management of outsourced studies
  • Experienced defining, entering, processing, reviewing, and validating clinical data; and understanding and following clinical trial protocols and data collection documents
  • Demonstrated knowledge in current data management processes, clinical trial methodologies, medical terminology, and regulatory requirements
  • Proficiency in data management software and systems (e.g., EDC systems, clinical trial data management systems)
  • Organizational and project management abilities, with a key eye for detail
  • Exceptional verbal and written communication skills and demonstrative problem-solving abilities within a highly collaborative environment

 

A Snapshot of Nimbus 

Our Science  

At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.  

Our Culture 

Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.  

Our Company 

Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Boston, Massachusetts. Learn more about us by going to www.nimbustx.com 

Join Nimbus. We are making a difference and you can too. 

At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.

 

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