Project Manager, Clinical Trials - Karachi Division - Massachusetts General Hospital

Description

The Massachusetts General Hospital is seeking a highly motivated individual to manage our clinical programs. This role will oversee and manage the Down syndrome and Huntington Disease clinical translational programs and clinical trials research under general direction from the Principal Investigator.

Key Responsibilities

• Manage all aspects of the clinical research protocol, including clinical and neuropsychological assessments, training and supervision of staff, and ensuring clinical databases are up-to-date.
• Oversee study-related documents, including Institutional Review Board protocols, Investigational New Drug applications, and regulatory documents.
• Interpret and apply GCP and IRB policies to support research compliance.
• Coordinate training for clinical coordinators/staff, assess competency, and manage assessment of data acquisition and analysis.
• Establish and monitor safe, compassionate practices in clinical research, providing a high-quality environment for patient-oriented research.
• Assist with Clinical Trial Monitoring visits and internal/external reviews.
• Develop, evaluate, and standardize operating procedures (SOPs) and troubleshoot issues.
• Supervise and manage staff, provide resources for patients and staff, and recruit participants for research protocols.
• Responsible for clinical study assessments, phlebotomy, infusions, EKGs, and other clinical assessments.

Regulatory Compliance

• Provide oversight and advise Clinical Research staff on FDA, OHRP regulations, GCP, and NIH guidelines.
• Participate in the design and implementation of new proposals and projects.
• Assist with IND applications, if needed.
• Plan and conduct project team meetings, participate in training opportunities, and develop SOPs.
• Lead the execution of high-quality clinical research projects, leveraging knowledge and expertise.
• Build effective teams via communication, decisiveness, and technical expertise.
• Communicate with regulatory agencies, funding agencies, and safety monitoring boards.
• Troubleshoot study/portfolio related issues and escalate as necessary.

Skills and Abilities

• Must have formal supervisory experience.
• Excellent written and verbal communication skills.
• Advanced time management and analytical skills.
• Ability to organize information and handle sensitive information with confidentiality.
• Working knowledge of software applications, including Microsoft Word, Excel, PowerPoint, RedCap, EPIC.
• Ability to make decisions independently and seek information when needed.
• Problem-solving skills, dependability, and flexibility as a team player.

Education and Experience

• BS degree in a health-related field.
• Nursing degree with nursing licensure preferred.
• 5+ years of related clinical trials experience strongly preferred, with a minimum of 2-3 years of clinical research experience.

Working Conditions

• This is a fully onsite position at the Charlestown Navy Yard, outpatient clinics, and inpatient units at MGH.