Senior Director, Clinical Data Management

4 weeks ago

Cambridge Massachusetts, United States Editas Medicine Full time
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Reporting to the VP of Biometrics, the Director/Sr. Director, Clinical Data Management is responsible for all clinical data management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data. This person is expected to be a highly experienced functional area project and people leader with expert knowledge of Data Management strategy, operations and processes, and excellent people leadership skills.

Key Responsibilities:

As the Director/Sr. Director, Clinical Data Management, you will be responsible for:

Provide leadership and drive strategic direction of Data Management

Provide guidance and mentorship to direct reports

Develop DM standards and procedures

Review/approve DM-related documents (e.g. eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines), as applicable

Manage DM resources and contracts

Drive the selection, collaborations and oversight of CROs and external vendors to ensure efficiency, quality, and consistency for all DM deliverables

Develop and maintain expert competencies within Data Management

Ensure compliance with regulatory and industry process and quality standards

Represent DM in regulatory inspections

Collaborate with cross-functional leads to ensure team effectiveness

Requirements

The ideal candidate will possess:

Bachelor’s degree in the scientific/healthcare or related field; Master’s or Advanced degree preferred

A minimum of 12 years (Director) to 15 years (Sr. Director) of professional DM experience in Pharmaceutical, Biotech, or CRO industry

Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred

Significant end-to-end, hands-on experience in all aspects of data management

Significant experience working with clinical trials

Significant experience and extensive knowledge of the complex and interdependent relationships between protocol development, data collection, data review, and cleaning activities, analysis and reporting

Significant experience leading data management activities for clinical trials; expert knowledge of DM processes, tools, methodologies and documentation; expert understanding of DM strategy

Significant experience with EDC platforms and database design, including Medidata Rave and Oracle Clinical Inform

Significant experience of clinical DM outsourcing with full service global CROs and niche providers

Knowledge of GCP, FDA, ICH, CDISC, CDASH regulations and guidelines

Experience in resource and budget management

Experience in regulatory inspections

Excellent verbal and written communication skills

Benefits

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

Fostering Belonging. Fueling Innovation. Transforming Lives.

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