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Clinical Operations Associate Manager

2 months ago


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

The Multiple Myeloma Research Foundation (MMRF) is seeking a highly skilled Clinical Operations Associate Manager to join our team. As a key member of our clinical operations team, you will be responsible for providing project management support and oversight of assigned translational and clinical research projects.

Key Responsibilities
  • Oversee and support the management of clinical and translational research projects, including clinical trials and observational studies involving human subjects, biospecimen collection and analysis, clinical site operations, and contract research organization (CRO) and other research vendor engagement.
  • Partner with study team to develop and drive timelines for clinical and translational studies.
  • Develop and partner with study team to manage and adhere to research study project plans, timelines, Gantt charts, metrics, presentations, and other relevant documents.
  • Report on study progress to MMRF clinical operations and translational research leadership.
  • Prepare and present project reports as required.
  • Plan, execute, and lead study-specific meetings as required, both internal and external (investigator/site-based).
  • Interface with key departments to discuss status of current studies at The MMRF, as well as strategies for any potential challenges, including but not limited to staffing, vendor, or site issues.
  • Provide support for the development of study budgets, vendor, and site payments.
  • Prepare and/or review study-related documents as appropriate (e.g., Protocol, Study Operations Plan, Monitoring Plan, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets, and other study-specific documents or manuals).
  • Review and provide input on study data forms.
  • Prepare and facilitate IRB submissions to central IRB.
  • Engage with biorepository laboratories to manage shipment, storage, and tracking of samples, results, and other relevant materials.
  • Ensure audit-ready condition of study documentation, including central research files (i.e., trial master file (TMF)) and general research documents.
  • Support and contribute to the writing and review of study protocols, informed consents, and associated amendments.
  • Provide support for the development of statements of work (SOW) for research vendors.
Requirements
  • Bachelor's Degree (BA, BS) in scientific or health care discipline preferred.
  • Minimum of 5 years of pharmaceutical, biotech, academic research site, or CRO-related experience.
  • Laboratory experience (molecular, biology, chemistry, genetics) experience preferable.
  • Oncology research experience required.
  • Experience with creating and submitting study documents to IRB.
  • Ability to manage complex research protocols within a matrix environment.
  • Experience in working with Contract Research Organizations (CROs) or other external vendors.
  • Excellent working knowledge of ICH GCP Guidelines.
  • Excellent team player; willingness and ability to fill functional gaps in a small organization.
  • Effective oral, written, and interpersonal communication skills.
  • Flexible, adaptable to change.
  • Computer literacy required (MS Word, MS Excel, MS PowerPoint, and MS Project).
  • Strong project management skills.
  • Strong organizational skills.
  • Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Ability to travel as necessary (up to approximately 10%).
About the MMRF

The Multiple Myeloma Research Foundation (MMRF) is a nonprofit organization dedicated to accelerating a cure for multiple myeloma patients. We drive the development and delivery of next-generation therapies, leverage data to identify optimal and more personalized treatment approaches, and empower myeloma patients and the broader community with information and resources to extend their lives.

We are committed to our core values of Prioritizing Patients, Driving Innovation, Delivering Solutions, Doing It Together, and Building Trust.