Associate Director/ Director, Clinical Data Management
Reporting to the Head of Clinical Data Management, the Associate Director / Director, Clinical Data Management will be responsible for leading the data management processes for the Oncology and Rare Diseases therapeutic areas at Moderna.
Here's What You'll Do:
- Lead the data management partnership with CROs for studies in the Oncology and Rare Diseases therapeutic areas
- Develop and/or write the database design, edit checks, CRF completion guideline and Data Management Plan for in-house data management activities/studies
- Participate in the Data Standards Committee and act as the liaison between the study team members in Oncology and Rare Diseases to standardize data collection and reporting
- Work in partnership with the Director, Data Standards and Integration to ensure seamless data integration with the other Moderna therapeutic areas and/or CRO partnerships
- Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure that project timelines and goals are met effectively and within budget
- Attend all study team meetings to provide updates and issue resolution
Here's What You'll Bring to the Table:
- Master's or Bachelor's Degree in computer science or a science-based subject with at least 10-15 years of clinical data management experience in industry, with experience across indications and EDC platforms (or Doctorate with at least 5 years of experience in industry); or a Bachelor's Degree outside of computer science or a science-based subject with a minimum of 12-18 years of clinical data management experience in industry, with experience across indications and EDC platforms
- At least 3-5 years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
- Vendor management and oversight experience
- Strong technical skills across data platforms
- Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
- Cross collaboration proficiency with other departmental functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
- Experience in regulatory GCP inspections/audits
- Experience with Spotfire or other data visualization software
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Ability to manage multiple projects in a fast-paced environment
- Creative, capable problem-solver
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.