Manager, Research Studies

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

• Bachelors degree in research nursing public health clinical research health sciences epidemiology informatics or a related field; masters 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.

The American Society for Hematology (ASH) is dedicated to cultivating a workplace that prioritizes fairness respect and equal opportunity for all employees. We maintain a strict non-discrimination policy and are committed to treating each other with dignity regardless of race color sex religion age sexual orientation gender identity or expression national origin disability genetic information pregnancy veteran status or any other characteristic that is protected by federal state or local laws. Our goal is to foster an inclusive environment where everyone can thrive contribute and achieve their full potential.