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Director, Clinical Data Management

4 months ago

Cambridge, United States BioSpace Full time
Job Details

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director Clinical Data Management, this individual will report to the Senior Director Clinical Data Management to be responsible for effective leadership, strategic planning, and oversight at the portfolio level within the Global Clinical Data Management function. This position requires working with key stakeholders and leading clinical data management activities to support regulatory submissions, inspections, and audits. You will be responsible for overseeing clinical data management teams to execute activities to ensure high quality data. You will lead strategy development for the assigned area and development and implementation of clinical data management policies, SOPs, processes, clinical systems, documents, and other tools.

What you'll do
  • Serve as data management lead for multiple products or indications of considerable complexity
  • Provide input on vendor and technology evaluation, selection, and performance
  • Lead CDM strategies for the assigned area
  • Oversee and direct the design and implementation of the CDM process with vendors, including clinical systems design, build and testing, data integration, data review, dictionary coding, data quality checking, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems
  • Review and author technical documents including reports, process descriptions, SOPs, data management plans, data transfer agreements, reconciliation plans, and related documents at the study and department levels
  • Provide technical and business process expertise on new and emerging technologies / vendors for clinical trial execution
  • Lead and manage a team of direct reports and may manage other people leaders
  • Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
  • Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
  • Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
  • Innate ability to assess talent that will help grow the organization and add to Sana's culture

What we're looking for
  • Progressive experience in clinical data management in the pharmaceutical, biotechnology, or CRO industry of at least 10 years
  • Extensive background collaborating with CROs, vendors, and internal study teams
  • In-depth knowledge and experience with different clinical systems such as electronic data capture (EDC) systems, IRT and other data collection systems
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Sana SOPs and ensures the same across own team
  • Broad knowledge and clear understanding of Food and Drug Administration (FDA) requirements related to electronic systems and records; strong understanding of guidelines as they relate to CDM, including Good Clinical Practice (GCP) and International Council on Harmonisation for Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines

What will separate you from the crowd
  • Highly competent in clinical data management and use of technology for data capture including data visualization tools

What you should know
  • The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together for patients
  • Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal .

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.