Manager/Senior Manager, Clinical Data Management
Moderna is seeking a Manager/Senior Manager, Clinical Data Management to work across its programs. This position will initiate best practices and lead clinical data management initiatives across the ventures as well as support the oversight of data management vendors and data handling. This role will report to the Head of Therapeutic Operations at Moderna.
Here's What You'll Do:
- Develop data collection standards for Moderna
- Develop best practices for data handling
- Consult with CROs to solve operational data issues
- Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
- Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements
- Ensure timing and integrity of data transfers from all vendors
- Review data analysis listings and report on performance and quality
- Review clinical data within studies and across for trend analysis
- Support the strategy for data cleaning to ensure timely deliverables
- Support the data collection through efficient eCRF and database design
Here's What You'll Bring to the Table:
- Bachelor's Degree in a science-based subject expertise.
- At least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms
- Early and late development experience
- Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc.
- Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Creative, capable problem-solver
Here's What We'll Bring to the Table:
- The opportunity to impact the lives of patients with cancer utilizing one of the most exciting innovations in the field of immune-oncology
- 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
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 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 of vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays
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.