Associate Manager, Clinical Operations

MMRF CORE VALUES:

At the MMRF our core values define both who we are and how we work together as an organization. We believe in investing in our team and building a culture that will help us pursue our highest-level mission to accelerate a cure for each and every multiple myeloma patient. Our five core values are expressed below:

• Prioritize Patients - Patients are at the center of everything we do. Every decision we make is grounded in the needs and best interests of the patients we serve.
• Drive Innovation - We are committed to pursuing big, bold ideas. Taking risks, trying new approaches, and challenging the status quo are necessary to speed new discoveries.
• Deliver Solutions - Taking on complicated challenges is what sets us apart. To deliver results, we must be decisive, take action, and act with urgency on behalf of the myeloma community.
• Do It Together - We know that together, we are stronger. We work cross-functionally with the entire community to achieve our mission and are invested in the success of others.
• Build Trust - We build trust-based relationships. We advocate for each and every myeloma patient by committing to diversity, equity, and inclusion and treating others with respect.

Reporting into the Senior Study Manager, the Associate Manager, Clinical Operations, is responsible for providing operational management support in the conduct of MMRF clinical trials and translational research studies.

• 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.

• 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.

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/facilitate any type of work authorization for this role. All applicants must currently have original 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.