Clinical Research Manager

Site: Mass General Brigham Incorporated

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination monitoring and regulatory oversight of Investigator-initiated multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to provide managerial operational and supervisory oversight for a team of research coordinators/monitors and their respective research trials.


The Clinical Research Project Manager will independently direct a team of research staff to coordinate monitor and advance a portfolio of therapeutic oncology trials from concept through completion. Project Manager responsibilities include direct management of individual trials in addition to the hiring training and first-line supervision a team of research staff and the day-to-day operations other their research portfolios. The Project Manager has oversight responsibility of the teams timeline management clinical quality assessment and trial operations integrity and for ensuring Sponsor-Investigator and Site Investigator compliance with Federal and local regulatory requirements. The Clinical Research Manager provides input into the assessment of program procedures and staff management while maintaining a working knowledge of all aspects of clinical research management.

Manager responsibilities include:


Trial and portfolio coordination

Coordination regulatory maintenance monitoring and timeline management of several multi-center clinical trials within the Cancer Center

Ongoing evaluation and verification of protocol procedures regulatory and data compliance and alignment with federal and local regulations across all participating sites

Act as central communications liaison for all clinical trial collaborators

Work directly with entities within and outside the organization including Investigators funding sponsors collaborators and vendors to establish workflow monitor process and identify and resolve issues

Identify variance across participating sites Standard Operating Procedures and developing processes to ensure compliance

Fulfill routine and expedited reporting requirements to all funding sponsors monitoring boards regulatory boards or other governing agencies (e.g. FDA IRB DSMB etc)

Occasional domestic travel required (<25%)


Supervisory:

Provide first-line supervision to a minimum of 2-4 FTEs and/or assist with specialized management projects of equivalent responsibility.

Hiring and training of new staff and assessment of ongoing continuing education and development needs of supervisees

Executing performance evaluation staff development and corrective action processes for direct report research staff as needed

Manage staff productivity and quality of work produced by assessing work effort on individual studies.


Management Team Responsibilities:

Assist and consult with Senior PCORP Management on global program initiatives including networking program expansion and process improvement

Stay current with federal and local regulations guidance and quality assurance trends as they pertain to the conduct of clinical research. Assist in update and development of program operations to align with guidance.

Skills Required:

Exceptional time management skills with the capacity to prioritize among multiple tasks and change direction in response to fluctuating demands

Excellent written and verbal communication skills

Ability to clarify and distill complex issues to a variety of collaborators

Able to work successfully and independently in a remote environment while demonstrating and fostering initiative and accountability

Able to manage diverse teams with different skillsets work styles and professional roles

Motivated to help 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 develop alternatives

Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)

Knowledge of current and developing clinical research trends

Sound interpersonal skills

Job Summary

Summary
The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s).

Does this position require Patient Care
No

Essential Functions
-Collaborating with project investigators and research sites to ensure targets are met for study start up site activation patient recruitment and enrollment.

-Safety management and reporting to FDA Data and Safety Monitoring Boards Medical Monitors funding agencies and other regulatory bodies.

-Collecting reviewing and approving of all required regulatory documents; and working to ensure the study Trial.

-Managing multi-center trials funded by NIH Industry standards.

-Collaborate with grants management team to prepare progress reports.

-Provide safety management oversight for studies in collaboration with study PI and safety boards.

Education
Bachelors Degree Related Field of Study required or Masters Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree
No

Licenses and Credentials

Experience
Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred

Knowledge Skills and Abilities
- Strong organizational and communication skills.
- Demonstrated analytical skills.
- Effective problem solving skills.
- Ability to supervise and train staff effectively.
- Strong database management and computer skills.
- Must possess aptitude for budget management.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• 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%)

Remote

101 Merrimac Street

40

Regular

Day (United States of America)

Pay Range

$62004.80 - $90750.40/Annual

Grade

7

At Mass General Brigham we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive and any offer extended will take into account your skills relevant experience if applicable education certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

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