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Multiple Myeloma Research Foundation - MMRF · 3 days ago

Associate Manager, Clinical Operations

Norwalk, CT

Full-time

Hybrid

Mid, Senior Level

5+ years exp

The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit organization focused on accelerating a cure for multiple myeloma patients. The Associate Manager, Clinical Operations will provide operational management support for clinical trials and translational research studies, ensuring effective communication and coordination among various stakeholders.

CharityHealth CareNon Profit

Diversity & Inclusion

No H1B

U.S. Citizen Only

Responsibilities

Provides clinical operations support for the MMRC Horizon adaptive platform trials including communications with MMRC sites, CROs, trial vendors, pharma partners and other duties as assigned

Under the direction of the Senior Study Manager, manages the development of trial documents, review of study materials, and facilitation of document review

Follows up with sites regarding clinical data issues, ensuring data is entered in a timely fashion

Prepares, submits and maintains study documents to the IRB

Provides support to management in the development of FDA communications and submissions

Establishes, updates, tracks, and maintains study-specific trial management tools/systems, and status reports as required

Facilitate with drug depot, ensure appropriate inventory is available throughout the trial, liaise between drug depot and CRO

Provides support for safety report review, submission preparation and documentation, communicating with medical and other stakeholders to ensure timely review and follow up

Work with vendors to ensure study systems are functioning per protocol and sponsor requirements

Collects, aggregates, and reports on MMRC study data

Develops PPT presentations and other documents as directed

Communicates effectively with team members and management relaying protocol/study related issues and proposed solutions

Assists with review of clinical study reports

Follows internal electronic filing guidelines and maintains accurate study files

Performs other duties as assigned by management

Qualification

Oncology clinical trials managementClinical trial regulations knowledgeMS Office suite proficiencyCommunication skillsProblem-solvingAttention to detailTeam collaborationAdaptability

Required

Bachelor's Degree required

Minimum of 5 years of oncology clinical trials coordination or management required

Working knowledge and comfort with MS Office suite (PPT, Word, Excel, Outlook, TEAMS)

Excellent communication skills (verbal and written)

Problem-solving and attention to detail for the ability to deliver on specific study activities

Friendly, flexible, adaptable, and eager to learn new skills, collaborate, and work closely with team members and leadership

Working knowledge of clinical trial regulations (FDA, OHRP) and ICH GCP guidelines

10% domestic travel required

Company

Multiple Myeloma Research Foundation - MMRF

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.

Founded in 1998

Norwalk, Connecticut, USA

51-200 employees