Position Summary The Manager, Research Studies leads the day-to-day planning and execution of assigned studies prioritized by the ASH Research Collaborative and its Research Networks. The position manages studies working with Network investigators, industry, government, foundations, and other external or internal parties and helps ensure that each study is delivered in accordance with the approved scope, protocol, budget, timeline, data requirements, and applicable research and privacy requirements.
Working under the direction of the Deputy Director, Data Hub, the Manager collaborates with investigators, participating sites, patient and community participants, internal teams, contractors, funders, and other partners throughout the study lifecycle. The position manages research workflows, IRB and consent requirements, study start-up, site implementation, study documentation, data quality coordination, issue resolution, funder deliverables, and closeout activities. The Manager works closely with other ASH RC teams to support successful study execution.
Essential Duties and Responsibilities Research Study Planning and Execution
- Lead day-to-day management of assigned research studies from planning and start-up through execution, dissemination, and closeout.
- Translate approved study concepts, protocols, scopes of work, and funding commitments into actionable project plans, timelines, milestones, responsibilities, and deliverables.
- Monitor progress against protocol requirements, contractual deliverables, budgets, and timelines; identify risks early and implement or escalate corrective actions.
- Facilitate study meetings, document decisions and actions, and ensure timely follow-through.
- Manage one or more assigned studies and priorities while maintaining visibility into workload, dependencies, and resource needs.
Protocol, Regulatory, and Research Compliance
- Orchestrate development, review, and implementation of study protocols, research plans, data collection requirements, and study materials.
- Manage IRB submissions, reliance arrangements, continuing reviews, amendments, reportable events, and study closeout requirements in conjunction with investigators, sites, and designated regulatory partners.
- Oversee informed consent and authorization processes when applicable, including development of materials, site training, documentation expectations, and issue resolution.
- Maintain complete and current study documentation, including approvals, training records, decisions, deviations, and required reports.
- Track protocol deviations, noncompliance, and other study issues; coordinate assessment, documentation, corrective actions, and required reporting.
- Ensure study activities are conducted in accordance with approved protocols, contracts, ASH RC policies, research ethics, HIPAA, data use agreements, and applicable regulatory requirements.
- Escalate compliance, participant safety, privacy, or data integrity concerns promptly to the appropriate leaders and experts.
Site and Participant-Facing Research
- Conduct study feasibility, site selection, start-up, activation, training, implementation, monitoring, and closeout activities for participating sites.
- Working with relevant Program Operations Managers, serve as a central point of coordination for site research teams and develop study-specific training, implementation guidance, and supporting materials.
- Guide patient- and caregiver-facing research activities and engagement with patient and community collaborators when included in the study design.
Research Data and Analysis
- Translate protocol and study objectives into clear research data, cohort, quality, and analytic requirements in partnership with investigators.
- Manage development and review of study specifications, data collection tools, data management plans, analytic plans, and study-specific quality requirements.
- Monitor study data readiness, completeness, quality findings, query resolution, and analytic dependencies; coordinate corrective actions and escalation as needed.
- Oversee study-specific data quality interactions with sites in collaboration with the related Program Operations Manager.
- Support abstract, presentation, manuscript, and other dissemination activities, including timelines, contributor coordination, reviews, approvals, and submission tracking.
Deliverable Management
- Lead communication with study funders/sponsors, investigator, committee, and scientific leadership regarding study plans, progress, risks, decisions, deliverables, and changes in scope or timeline.
- Support development of research proposals, scopes of work, budgets, timelines, and feasibility assessments for prospective Data Hub studies.
Qualifications, Knowledge, and Skills - Bachelor's degree in research nursing, public health, clinical research, health sciences, epidemiology, informatics, or a related field; master's degree or advanced clinical or research training preferred.
- At least five years of progressively responsible experience managing clinical, observational, registry-based, real-world data, or other health research studies.
- Demonstrated knowledge of the research study lifecycle, including protocol implementation, IRB oversight, informed consent, site start-up, study documentation, deviations, data management, and closeout.
- Working knowledge of HIPAA, data use agreements, research ethics, human subjects protections, and applicable regulatory and data-sharing requirements.
- Excellent written and oral communication skills, including the ability to communicate research requirements and risks to clinical, scientific, technical, and executive audiences.
- Strong judgment, organization, attention to detail, problem-solving, diplomacy, and follow-through.
- Ability to manage multiple studies and shifting priorities in a collaborative, deadline-driven environment.
- Demonstrated proficiency with Microsoft Word, Excel, PowerPoint, and research or project management systems.
- Ability to handle confidential information and participate in periodic non-traditional hours, remote work, and travel.
Physical Requirements- Ability to communicate verbally and listen actively.
- Ability to use computers, telephones, and other standard office equipment.
- Ability to travel periodically for study meetings, site activities, and other business needs.
