Clinical Trial Manager, Clinical Operations
The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Clinical Operations Leader in the assigned Therapeutic Area.This role maywork collaborativelyon one trial or across several trials to support clinical operations activities.
Here's What You'll Do:
- Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
- Communication to internal team members on deliverables and ensuring timelines are met
- Manage trial feasibility process
- Drafting site materials including training, manuals and support documentation
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings
- Periodic review of clinical data
- Review of clinical monitoring reports to ensure timely completion and identification of issues
- Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
- Maintain trial metrics
- Ensure trial is conducted in accordance to Moderna and ICH/GCP standards including multiple regions in global trials
- Support the CRO in testing clinical trial systems/databases (i.e. UAT)
- Develop and maintain strong, collaborative relationships with key stakeholders within Moderna
Here's What You'll Bring to the Table:
- At least 5 five years of trial coordination experience in a clinical research environment, some should be in industry
- Advanced degree preferred or Bachelor's in a science-based subject
- Relevant therapeutic experience in global setting
- Solid understanding of drug development
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Excellent verbal and written communication skills
- Good organizational skills and attention to detail
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
- 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' 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.