Apply on Employer Site

Multiple Myeloma Research Foundation - MMRF · 1 week ago

Associate Study Manager

Norwalk, CT

Full-time

Onsite

Mid, Senior Level

5+ years exp

The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit focused on accelerating a cure for multiple myeloma patients. The Associate Study Manager will lead operational planning and execution of clinical research studies, ensuring compliance with regulatory standards and collaborating with cross-functional teams to deliver high-quality data.

CharityHealth CareNon Profit

Diversity & Inclusion

No H1B

Responsibilities

Manage all aspects of the study, including responsibility for oversight of study execution, develop and manage comprehensive study timelines and metrics; management/oversight of external vendor deliverables reports and budgets

Study design and planning: Actively participate in protocol development, feasibility assessments, site selection, and budget planning for assigned studies. Write and review study protocols, informed consent forms, and amendments, as appropriate

Manage and report on study budget, working closely with finance and accounting

Manage/track study budget progress, expenses, vendor, pharma/biotech partner invoices, and study site payments

Prepare study reports and disseminate, present, and inform on all aspects of the study progress to MMRF leadership and cross functional teams

Prepare and present project reports as required

Plans, executes, and leads study-specific meetings as needed (e.g., Study Management Meetings, site calls etc.)

Risk management: Proactively identify potential risks associated with the study and implement mitigation strategies

Develop and facilitate requests for proposals (RFP) for all study vendors, including and others, as appropriate, under the direction of the Associate Director, Clinical Operations

Conduct critical analysis of areas of risk; identify, manage or escalate risks as appropriate

Ensure that study issues and action items are addressed, closeout appropriately and in compliance with study management plans

Prepares and/or reviews and takes accountability for the accuracy of study-related documents

Accountable for study-specific legal agreements and other legal documentation as required for vendors, pharma partners, sites, etc

Ensures audit-ready condition of study records and documentation, both electronic and paper

Develops internal processes for improved efficiencies associated with study management

Develops, reviews and is responsible for the maintenance of study-specific standard operating procedures (SOPs)

Prepare and submit regulatory documents to central IRB. Manage all study IRB and other regulatory documents

Qualification

Clinical study operationsClinical project managementRegulatory document submissionMedidata RaveTranslational researchGCPFDAICH GuidelinesBudget managementComputer literacyInterpersonal skillsTeam playerOrganizational skillsCommunication skillsLeadership capability

Required

Bachelor's Degree (BA, BS) in scientific or health care discipline required; master's degree preferred

Minimum 5 years of clinical study operations experience in pharmaceutical, biotech, academic, or CRO settings, preferably within oncology

Demonstrated ability to manage complex protocols and deliver results in a matrixed environment

Strong experience in clinical project management including study start-up, conduct, and closeout

Experience in working with external research vendors is required

Hands-on experience with Medidata Rave including eCRF management, database oversight, and query handling

Solid financial acumen, including study budgeting, invoice processing, and site payment management

Experience in drafting and reviewing study protocols, informed consent forms, etc

Experience preparing and submitting regulatory documents to IRBs

Excellent working knowledge GCP, FDA and ICH 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

Strong interpersonal, written, and verbal communication skills; collaborative team player willing to support adjacent functions when needed

Ability to work efficiently within established workflows while contributing to a culture of respect, flexibility, and continuous improvement

Demonstrated ability to work effectively within diverse team environments, adjust to evolving project requirements, and incorporate feedback appropriately

Computer literacy required (MS word, MS Excel, MS PowerPoint, and MS Project)

Demonstrated leadership capability and professional communication style

Strong organizational skills

Ability to travel as necessary (approximately 10%)

Preferred

Master's degree

Translational research experience preferred

Hematology Oncology therapeutic experience strongly preferred

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