Project Manager I

Project Manager Responsibilities

Responsibilities include, but are not limited to, the following activities:

Technical and Scientific Responsibilities

* Support PI(s) with manuscript, abstract, and presentation preparation for local and community stakeholders.
* Under supervision of PI, perform independent quantitative and qualitative analyses of ongoing study data and conduct literature reviews to identify new research questions and support scientific dissemination.
* Supervise and perform data quality checks and data management tasks using statistical analysis software (e.g., Stata) and manage study REDCap databases.
* Facilitate communication and coordination of study activities between study site and stakeholders, such as but not limited to MGH research teams and outpatient clinics, study sponsors and central reading centers to develop and implement workflows for advanced clinical testing, including current, in-development, and proposed procedures.

Logistical and Administrate Study Management Responsibilities

* Identify and monitor project goals, deliverables, tasks, and timelines.
* Develop new standard operating procedures (SOPs) and workflows and lead launch of new study procedures and project tools including but not limited to Asana, VeevaVault, Twilio, OnCore, etc.
* Maintain research files and case report forms (CRFs) for documentation of study participant visits.
* Ensure research integrity and compliance by developing best practices, provide ongoing training, and monitoring for adherence to applicable regulations as well as communicating with institutional review boards.
* Serve as a liaison between the financial management team and the research team.
* Provide expertise and problem-solving in research-related participant care including but not limited to study monitoring, audits, participant retention, and deviation and adverse event reporting.
* Run weekly staff meetings to promote forums for communication of information and opportunities for team discussion and problem-solving.

Managerial/Personnel Responsibilities
* Facilitate MGH's RECOVER staff recruitment effort by interfacing with HR, conducting interviews, and participating in hiring decisions.
* Coach and develop Clinical Research Coordinators (supervisory responsibilities may also be assigned, depending on experience) and onboard new study staff by creating training schedules, providing performance feedback, and developing role-specific competencies.
* Proactively take steps to help others move forward, whether it is planning project- specific meetings, getting people to make decisions, enlisting additional resources, etc.
* Promote collaboration and a work environment conducive to teamwork and employee engagement.

Competencies required:

Planning, Organizing, and Coordinating
* Skilled in identifying opportunities to improve the efficiency of research operations and subsequently execute improvements.
* Time management skills with the capability to prioritize among multiple requests from multiple individuals and the ability to change direction in response to a fluctuating work environment.
* Ability to delegate and prioritize and assist others with prioritizing study tasks.

Team Management
* Ability to work successfully in a collaborative environment.
* Ability to manage diverse teams with different skillsets, work styles, and professional roles.

Gets Results/Takes Initiative
* Motivated to help the team achieve results and meet deadlines.
* Identifies key priorities and helps manage change and ambiguity.
* Keen ability to anticipate and address potential issues proactively.
* Problem-solving skills, including the ability to gather information, identify resources, and imagine alternatives.

Communication Skills
* Excellent written and verbal communication skills.
* Ability to represent MPEC and RECOVER with the utmost professionalism and ability to build strong relationships inside and outside the group.
* Cognizant and respectful of cultural differences; bilingual and bicultural candidates are particularly encouraged to apply.

Analytical Skills
* Intellectual curiosity and willingness to learn.
* Rigorous academic and/or professional background including healthcare work, clinical trials, or other research activities.
* Familiarity with clinical research.

This description has been designed to indicate the general nature and level of work performed by an employee within this position. The actual duties, responsibilities, and qualifications may vary based on need.

Qualifications:

* Bachelor's degree and 2+ years working in healthcare or a clinical research setting; Master's degree preferred.
* Experience in a progressively responsible position with experience in managing all aspects of clinical research study implementation required.
* Sound knowledge of principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance required.

Working conditions:

Duties may be carried out in a hybrid office environment, with on-site time at MGH main campus in Boston and MGH Chelsea campus. Occasional evening or weekend work may be required.

Supervisory Responsibility:

The Project Manager will be responsible for providing daily guidance and expertise for a team of 6-10 research staff. Supervisory duties may be assigned, depending on experience.

Physical Requirements

• Standing Occasionally (3-33%)
• Walking Occasionally (3-33%)
• Sitting Constantly (67-100%)
• Lifting Occasionally (3-33%) 20lbs - 35lbs
• Carrying Occasionally (3-33%) 20lbs - 35lbs
• Pushing Rarely (Less than 2%)
• Pulling Rarely (Less than 2%)
• Climbing Rarely (Less than 2%)
• Balancing Occasionally (3-33%)
• Stooping Occasionally (3-33%)
• Kneeling Rarely (Less than 2%)
• Crouching Rarely (Less than 2%)
• Crawling Rarely (Less than 2%)
• Reaching Occasionally (3-33%)
• Gross Manipulation (Handling) Constantly (67-100%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)