Massachusetts General Hospital ? Clinical Trial Project Manager- WFH Hybrid ? Boston, MA ? Cambridge, MA

Job title: Clinical Trial Project Manager- WFH Hybrid

Company: Massachusetts General Hospital

Job description: GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Massachusetts General Hospital Stroke and Neurocritical Care Research Center is one of the largest and most prolific stroke research centers in the country employing a diverse team of clinical researchers managing novel clinical trials in stroke and vascular diseases. The Center?s staffing structure and project portfolio support professional growth of clinical research staff at all levels as well as successful facilitation of highly complex interventional trials and large-scale genetic, longitudinal and observational studies.

Reporting to and receiving direction from the Center Director, study PI and other senior management, the incumbent will be responsible for the day-to-day project management of assigned clinical research projects. He/she will oversee the successful execution of all study-related activities and will be responsible for protocol, SOP, operational system and training development and creation of study-specific materials. The incumbent will serve as principal liaison with staff of all levels and with all participating sites, vendors and sponsors to ensure successful execution of studywide activities and enrollment from study start-up through closeout. He/she will monitor studywide performance metrics and generate reports for study leadership and assist with financial monitoring, reconciling and reporting and act as the key point of contact for the study.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Responsible for the day-to-day project management and other site clinical research activities including but not limited to:
? Lead cross-functional teams in delivery of high-quality clinical research activities leveraging knowledge, expertise, and risk mitigation.
? Collaborate with study investigators and participating collaborators to ensure targets are met for study start up, site activation, patient recruitment and enrollment and monitors benchmarks from study launch through closeout.
? Develop and maintain study-specific regulatory documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials and other study-specific tools, resources and support materials.
? Assist with the design of case report forms, study portals, electronic data capture system and website.
? Collect, review and maintain required regulatory documentation and monitor for compliance with applicable clinical research standards and requirements.
? Proactively monitor study-wide metrics including recruitment goal attainment and identify impediments, propose and implement solutions.
? Draft and execute newsletters, slide decks and other summaries of study-wide progress and metrics.
? Serve as central point of contact for all study-related questions.
? Plan, manage and lead meetings and trainings including scheduling, creation and distribution of agendas and supportive materials, technical support, recording minutes and summarizing and distributing action items.
? Travel to study-specific professional meetings as needed.
? Work closely with GM on study budget related questions and invoicing (site payments, vendor contracts, monitoring and reconciliation of financial expenditures, etc.).
? Train, supervise and manage staff.
? Accept responsibilities for special projects, as requested.

WORKING CONDITIONS:

This role is expected to be onsite a minimum of 3 days per week, with the option to work the remaining days onsite or remotely.

Qualifications

QUALIFICATIONS:

Minimum Experience and Degree Requirements:

A bachelor?s degree and at least three years? prior experience in a related field required. A master?s degree and experience in project management within a clinical research setting preferred. Working knowledge of federal regulations and ICH/GCP Guidelines is preferred.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:
? Highly motivated self-starter with strong leadership, communication and presentation skills.
? Ability to interact well with others in a team environment and take initiative.
? Ability to independently identify impediments, problem-solve, develop effective solutions and make decisions with minimal guidance.
? Possess exemplary organizational skills and attention to detail with the ability to track the workflow of numerous projects and prioritize responsibilities.
? High-level of competence with computers is essential particularly with Microsoft Office Suite (Outlook, Word, PowerPoint, Excel), as well as electronic communication software packages. A strong aptitude for expanding current knowledge base and learning new technology is essential.
? Demonstrated analytical skills and a working knowledge of clinical research data management programs and practices.
? Ability to appropriately handle personal and confidential medical information
? Effective interpersonal skills to interact with all levels of hospital staff.

Expected salary:

Location: Boston, MA - Cambridge, MA

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