Manager, Clinical Trial Transparency & Disclosure

The Role:

The Clinical Trial Transparency & Disclosure team at Moderna is looking for an agile, self-motivated individual to serve as Results and Registration Manager within Clinical Trial Transparency & Disclosure. This individual will be responsible to process clinical results and registrations for global registries and all activities related to Trial Transparency & Disclosure and provide support to Transparency team. The successful candidate will be detailed oriented, self-directed, and with the ability to be flexible and manage workload to meet project timelines.

Heres What Youll Do:

• Serve as the Trial Transparency Results and Registration Manager and process results submissions for Ct.gov EUCTR, EUPASS.

• Assesses requirements for clinical trial registration and disclosure of results

• Prioritizes and performs the day-to-day operations of results/ registration disclosure, ensuring the timely completion, review and approval for studies conducted globally.

• Process and manage end to end operations and workflows for global registration/results disclosure activities.

• Makes appropriate decisions regarding the applicability and timing of clinical trial disclosure activities according to national laws, regulations, industry guidance and corporate position.

• Facilitates periodic review of active registrations to ensure records are updated or verified as required

• Work in a cross functional capacity to ensure compliance is maintained with all Legal and Regulatory requirements pertaining to all applicable clinical studies.

• Uses independent judgment to assess clinical trial disclosure prioritization and appropriate problem solving to determine escalation of issues to management.

• Coordinates and oversees the work of consultants and vendors.

• Addresses inquiries related to clinical trial disclosure activities.

• Work with IT, as needed, to implement technology solutions related to clinical trial disclosure

• Provide support to the overall Clinical Trial Transparency departmental goals and vision.

Heres What Youll Bring to the Table:

• BA/ MS degree or higher; 5 years in the biopharmaceutical industry with direct experience in registrations/ results submissions in the biopharmaceutical industry.

• 3-4 years preferred in a role that provide dislcosure management, statistics, transparency writing preferred.

• Hands on experience with TrialScope Disclose software (PharmaCM) and other transparency software products is required.

• Deep understanding of global transparency and disclosure requirements; excellent understanding of all aspects of ICH- GCP, FDA, EMA (CTR and CTIS) and EEA country guidelines, keen insight on CTT guidelines for clinical and regulatory submission documents; understanding of clinical development process is required.

• Demonstrate good verbal, written communication skills and facilitation skills with the ability to work with others and achieve objectives.

• High attention to detail and accuracy.

• High ethical standards, trustworthy, operating with absolute discretion

• Ability to work under pressure, and to work independently and collaboratively in a team environment.

• Works effectively within an evolving and dynamic matrix environment; has proven track record to quickly adapt to changing regulations, priorities, and deadlines.

• Strong organizational/prioritization skills for the management of multiple concurrent projects

• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, Adobe, and SharePoint) and experience and skill performing medical literature searches.

• Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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.

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