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Manager of Clinical Research Operations

2 months ago


Norwalk, Connecticut, United States Multiple Myeloma Research Foundation - MMRF Full time

About the Multiple Myeloma Research Foundation (MMRF):

The MMRF stands as the foremost nonprofit organization globally dedicated to hastening a cure for every individual affected by multiple myeloma. Our mission encompasses the advancement and provision of innovative therapies, utilizing data to pinpoint optimal and personalized treatment strategies, and equipping myeloma patients and the wider community with essential information and resources to enhance their quality of life. A core aspect of our mission is our unwavering commitment to promoting health equity, ensuring that all myeloma patients can reap the benefits of the scientific and clinical breakthroughs we strive for. Since our establishment, the MMRF has allocated over $500 million towards research initiatives, initiated nearly 100 clinical trials, and facilitated the introduction of over 15 FDA-approved therapies, significantly increasing the life expectancy of myeloma patients.

Core Values of MMRF:

Our core values are the foundation of our identity and guide our collaborative efforts as an organization. We prioritize investing in our team and fostering a culture that propels us towards our ultimate mission of finding a cure for every multiple myeloma patient. Our five core values are:

  1. Patient-Centric Approach: Every decision we make is rooted in the needs and best interests of the patients we serve.
  2. Innovation-Driven: We embrace bold ideas and are willing to take risks to accelerate new discoveries.
  3. Solution-Oriented: We tackle complex challenges decisively and with urgency to deliver results for the myeloma community.
  4. Collaborative Spirit: We believe in the strength of teamwork and work cross-functionally to achieve our mission.
  5. Trust Building: We foster trust-based relationships and advocate for diversity, equity, and inclusion.

Position Summary:

The Associate Manager of Clinical Operations will collaborate closely with clinical and translational research teams, providing essential project management support and oversight for assigned translational and clinical research initiatives, including clinical trials and observational studies involving human subjects, biospecimen collection, clinical site operations, and data gathering.

Key Responsibilities:

  • Oversee and assist in managing clinical and translational research projects, including clinical trials and observational studies, biospecimen collection and analysis, and clinical site operations, including engagement with contract research organizations (CROs) and other research vendors.
  • Collaborate with the study team to establish and maintain timelines for clinical and translational studies.
  • Develop and manage research study project plans, timelines, Gantt charts, metrics, and presentations in partnership with the study team.
  • Report on study progress to MMRF leadership in clinical operations and translational research.
  • Prepare and present project reports as necessary.
  • Plan, execute, and lead study-specific meetings, both internal and external (investigator/site-based).
  • Engage with key departments to discuss the status of ongoing studies and strategies for addressing potential challenges, including staffing, vendor, or site issues.
  • Support the development of study budgets and manage vendor and site payments.
  • Prepare and/or review study-related documents as needed (e.g., Protocol, Study Operations Plan, Monitoring Plan, Informed Consent, Laboratory Manual, CRF Completion Guidelines, and other relevant study documents).
  • Review and provide feedback on study data forms.
  • Prepare and facilitate IRB submissions to the central IRB.
  • Coordinate with biorepository laboratories to manage the shipment, storage, and tracking of samples and results.
  • Ensure that study documentation is audit-ready, including central research files and general research documents.
  • Contribute to the writing and review of study protocols, informed consents, and associated amendments.
  • Assist in developing statements of work (SOW) for research vendors.
  • Perform other duties as assigned by the manager.

Qualifications:

  • Bachelor's Degree (BA, BS) in a scientific or healthcare discipline is preferred.
  • A minimum of 5 years of experience in pharmaceutical, biotech, academic research sites, or CRO-related roles.
  • Laboratory experience (molecular biology, chemistry, genetics) is preferable.
  • Oncology research experience is required.
  • Experience in creating and submitting study documents to IRB is essential.
  • Ability to manage complex research protocols within a matrix environment.
  • Experience working with Contract Research Organizations (CROs) or other external vendors.
  • Strong understanding of ICH GCP Guidelines.
  • Excellent team player with a willingness to fill functional gaps in a small organization.
  • Effective oral, written, and interpersonal communication skills.
  • Adaptable and flexible in response to change.
  • Proficient in computer applications (MS Word, MS Excel, MS PowerPoint, and MS Project).
  • Strong project management and organizational skills.
  • Able to multitask in a fast-paced environment and adjust workload based on changing priorities.
  • Willingness to travel as necessary (up to approximately 10%).

Equal Employment Opportunity Statement:

The Multiple Myeloma Research Foundation (MMRF) is an equal opportunity employer and does not discriminate against any candidate based on race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, military and veteran status, sexual orientation, or any other factor protected by federal, state, or local law.

The MMRF does not sponsor or facilitate any type of work authorization for this role. All applicants must currently possess valid unrestricted authorization to accept new employment in any role in the U.S. with any employer. There is also no future employer-provided sponsorship for this role to obtain or extend authorization to work in the U.S.