Operations Research Analysis Manager jobs in Connecticut

MMRF OVERVIEW:

The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. 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. Central to our mission is our commitment to advancing health equity so that all myeloma patients can benefit from the scientific and clinical advances we pursue. Since our inception, the MMRF has committed over $500 million for research, opened nearly 100 clinical trials, and helped bring 15 FDA-approved therapies to market, which have tripled the life expectancy of myeloma patients. To learn more, visit www.themmrf.org.

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.

Position Overview:

Working closely with the clinical and translational research teams, the Research Project Manager will provide project management and oversight of assigned translational research projects involving human subjects, clinical site operations, site-based biospecimen and data collection.

Essential Functions:

Oversee and manage the operations of research projects involving human subjects, clinical site operations, biospecimen collection and analysis, including CRO and other research vendor engagement.

Oversee study execution, develop and manage comprehensive study timelines and metrics, management and oversight of external vendor deliverables reports and budgets.

Develop and manage research study project plans, timelines, Gantt charts, metrics, presentations, etc.

Report on all aspects of study progress to MMRF clinical research operations and translational research leadership.

Prepare and present project reports as required.

Plan, execute, and lead study-specific meetings as needed (e.g., Project Management meetings, site calls etc.).

Manage study budgets, and oversight of 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, and other relevant study documents)

Engage with biorepository laboratories to manage shipment, storage and tracking of samples, results, and so on.

Implement and manage all assigned research study agreements, such as confidentiality agreements, master services agreements, scopes of work, participating site agreements.

Ensure audit-ready condition of study documentation including central research files.

Write and review study protocols, informed consents and associated amendments.

Write and prepare regulatory documents for submission to IRB.

Write and review statements of work (SOW) for translational study vendors.

Qualifications:

Bachelor’s Degree (BA, BS) in scientific or health care discipline preferred.

Laboratory experience (molecular, biology, chemistry, genetics) experience preferable.

Minimum of 10 years of pharmaceutical, biotech, academic site, or CRO related/oncology research operations management experience, including study site management.

Ability to manage complex protocols within a matrix environment.

Experience in working with and overseeing Contract Research Organizations (CROs) or other external vendors.

Excellent working knowledge ICH GCP Guidelines.

Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Excellent team player; willingness and ability to fill functional gaps in a small organization

Effective oral, written, and interpersonal communication skills

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

Excellent team player; willingness and ability to fill functional gaps in a small organization

Ability to travel as necessary (up to approximately 10%)

EEO 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/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.