Clinical Consent Sr. Specialist, Clinical Biomarkers
2 months ago
The Role:
Moderna is currently seeking an experienced and highly motivated Clinical Consent Sr. Specialist
who is eager to develop their career in a fast-paced company.
The successful candidate will be responsible for editing and writing informed consent language for clinical biomarker research and biobanking across Moderna's clinical protocols in accordance with institutional policies, federal regulatory standards, and ease of understanding by research participants.
This will include executing on all activities related to informed consent of biospecimens and data collected as part of the Moderna's clinical trials.
The Clinical Consent Sr. Specialist will interact closely with stakeholders and continuously make improvements to related documents based on content, language, complexity, and reading level.
Here's What You'll Do:
- Act as subject matter expert (SME) in patient informed consent and regulatory topics to ensure adherence to local laws/regulations/requirements for biomarker research and biobanking
- Serve as biomarker contact for study-related inquiries from HAs/IRBs/ECs regarding biospecimens and biomarker objectives and negotiate related consent language
- Develop process to verify informed consent documents against protocols, re-writing and/or informing authors of any important missing information and inconsistencies.
- Use industry knowledge to monitor external trends that will affect biospecimen consent language and best practices regarding content, process and approach.
- Lead development and updating of ICFs, as well as policies, standard operating procedures (SOPs) and working procedures related to consent oversight.
- Manage development of a supplemental consent database for each clinical study.
- Maintain editorial integrity of Moderna's informed consent templates and guidance documents.
- Work independently (if applicable) on special research initiatives.
- University degree required, and at least 5 years of experience in clinical research.
- Experience working in the pharmaceutical industry and/or consumer health publishing
- Experience reviewing, drafting and negotiating a variety of contracts in the biotechnology and/or pharmaceutical industry is beneficial.
- Exceptional judgment and ability to identify, prioritize, and resolve issues quickly and independently.
- Experience working in a regulated environment, with at least a basic understanding of the regulations relevant to the protection of human research participants, including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations, and the Health Insurance Portability and Accountability Act (HIPAA).
- Ability to work independently while managing multiple priorities in a timely and effective manner.
- Flexibility to work in a fast-paced, dynamic environment.
- 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
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-
Clinical Consent Sr. Specialist, Clinical Biomarkers
2 months ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is currently seeking an experienced and highly motivated Clinical Consent Sr. Specialistwho is eager to develop their career in a fast-paced company.The successful candidate will be responsible for editing and writing informed consent language for clinical biomarker research and biobanking across Modernas clinical protocols in accordance...
-
Clinical Consent Sr. Specialist, Clinical Biomarkers
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is currently seeking an experienced and highly motivated Clinical Consent Sr. Specialistwho is eager to develop their career in a fast-paced company.The successful candidate will be responsible for editing and writing informed consent language for clinical biomarker research and biobanking across Modernas clinical protocols in accordance...
-
Oncology Clinical Biomarkers Specialist
1 week ago
Cambridge, Massachusetts, United States Randstad Life Sciences US Full timePosition Overview: We are seeking a skilled Contractor for Clinical Biomarker Development to enhance and manage biomarker strategies within clinical stage Oncology programs.Key Responsibilities:Utilize extensive knowledge and technical proficiency in various biomarker assays, particularly in the immuno-oncology sector, including NGS, scRNAseq, TCR...
-
Oncology Clinical Biomarkers Specialist
2 weeks ago
Cambridge, Massachusetts, United States Randstad USA Full timePosition: Contractor, Clinical Biomarkers – OncologyCompensation: $60-70 per hourContract Type: Potential for Permanent HireRandstad USA is in search of a Contractor specializing in Clinical Biomarkers to spearhead and implement biomarker strategies within our oncology clinical programs. This role will report to the Associate Director of Oncology, Clinical...
-
Sr. Manager, Clinical Biomarkers, Oncology
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Modernas Associate Director of Oncology, Clinical Biomarkers. The Senior Manager will work collaboratively across biomarker and translational teams (internal, external CROs) to ensure planning,...
-
Sr. Manager, Clinical Biomarkers, Oncology
2 months ago
Cambridge, Massachusetts, United States ModernaTX, Inc. Full timeThe Role:Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Moderna's Associate Director of Oncology, Clinical Biomarkers. The Senior Manager will work collaboratively across biomarker and translational teams (internal, external CROs) to ensure planning,...
-
Sr. Manager, Clinical Biomarkers Therapeutics
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Biomarker scientist to develop, drive, and execute biomarker plans across clinical-stage therapeutic programs. This position reports to Modernas Director of Clinical Biomarkers for Therapeutics. The Sr. Manager/Manager will work collaboratively across multiple clinical teams (internal and/or external CROs) to ensure the...
-
Director, Clinical Biomarkers
3 months ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Modernas Sr. Director of Infectious Disease, Clinical...
-
Oncology Clinical Biomarker Consultant
1 week ago
Cambridge, Massachusetts, United States Randstad Life Sciences US Full timePosition: Clinical Biomarker Contractor - OncologyLocation: Flexible (2-3 days/week)Contract Duration: 6 Month Contract with potential for Full-Time Employment based on performanceWe are looking for a Clinical Biomarker Contractor specializing in Oncology.Essential Qualifications:Master's or Doctorate in a relevant scientific discipline (e.g., Immunology,...
-
Director, Clinical Biomarkers
3 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Modernas Sr. Director of Infectious Disease, Clinical...
-
Senior Manager, Oncology Clinical Biomarkers
2 weeks ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timePosition Overview:Moderna Therapeutics is on the lookout for a Senior Manager specializing in Clinical Biomarkers to spearhead and implement biomarker strategies across our clinical Oncology initiatives. This role will report directly to the Associate Director of Oncology, Clinical Biomarkers.The Senior Manager will collaborate closely with both internal...
-
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director in the Biomarker Operations group within the Clinical Biomarkers Department to provide leadership and strategy to impact biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs. This position will lead collaboratively across all therapeutic area clinical teams...
-
Associate Director, Clinical Biomarkers Therapeutics
2 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker plans across clinical-stage rare disease programs. This position reports to Modernas Director of Clinical Biomarkers for Therapeutics. The Associate Director will work collaboratively across multiple clinical teams (internal or external CROs) to ensure planning, execution,...
-
Lead Clinical Biomarker Manager
2 weeks ago
Cambridge, Massachusetts, United States Randstad USA Full timePosition Overview:Randstad USA is seeking a Senior Manager of Clinical Biomarkers to spearhead the development and execution of biomarker strategies across clinical oncology initiatives. This role is pivotal in collaborating with both internal teams and external partners to ensure the successful delivery of biomarker data for clinical trials.Key...
-
Senior Clinical Biomarker Manager
2 weeks ago
Cambridge, Massachusetts, United States Randstad Life Sciences US Full timeSENIOR CLINICAL BIOMARKER MANAGER - ONCOLOGYHybrid Position: Onsite 2 Days Per WeekContract Duration: 4 Months with Possibility of ExtensionRole Overview:We are seeking a Senior Clinical Biomarker Manager to spearhead the development and execution of biomarker strategies across clinical-stage oncology initiatives. This role involves close collaboration with...
-
Clinical Biomarkers Lead
2 weeks ago
Cambridge, Massachusetts, United States Randstad Life Sciences US Full timeSENIOR CLINICAL BIOMARKER MANAGER - ONCOLOGYHybrid Position: Onsite 2 Days WeeklyContract Duration: 4 Months with Possibility of ExtensionRole Overview:We are looking for a Senior Clinical Biomarker Manager to spearhead the development and execution of biomarker strategies across various clinical stage oncology initiatives. This role requires collaboration...
-
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleModerna Therapeutics is seeking a highly skilled and experienced Senior Manager, Clinical Biomarkers and Oncology to join our team. This is a critical role that will be responsible for developing and driving biomarker plans across clinical stage Oncology programs.Key ResponsibilitiesDevelop and implement biomarker plans for clinical stage...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Biomarker leader to drive biomarker assay plans across clinical stage oncology programs. This position reports to Modernas Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams(internal, external CROs) to ensure biomarker assay development strategy, planning,...
-
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Biomarker leader to drive biomarker assay plans across clinical stage oncology programs. This position reports to Modernas Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams(internal, external CROs) to ensure biomarker assay development strategy, planning,...
-
Associate Director, Biomarker Statistics
2 weeks ago
Cambridge, United States Moderna, Inc. Full timeThe Role:This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Associate Director of Clinical Biomarkers will serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities...
