Clinical Trial Assistant Project Manager

Site: The General Hospital Corporation

 

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.

 

 

Job Summary

Summary<br>Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.<br><br>Does this position require Patient Care?<br>No<br><br>Essential Functions<br>-Manage multiple clinical trial sites for the duration of the trial. <br>
-Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review and/or approval. <br>
-Advise research sites on protocol conduct and interpretation, and ensure the resolution of any issues. <br>
-Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed. <br>
-Maintain a clinical trial database that includes the latest protocol versions and updated contact information. <br>
-Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits. <br>
-Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases. <br>
-Assist in the training and development of other junior staff members in key processes and procedures. <br>
-Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits. <br>

 

Qualifications

Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Previous Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferred Knowledge, Skills and Abilities - Demonstrated high-level proficiency in MS Office products (Word and Excel) and familiarity with databases. - Excellent interpersonal, communication, and problem-solving skills, along with attention to detail and follow-through. - Able to work objectively, exercise discretion, and maintain strict confidentiality. - Time management skills and the ability to function effectively within a changing environment. - Solid written and verbal communication skills.

 

Additional Job Details (if applicable)

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 Type

Hybrid

 

Work Location

399 Revolution Drive

 

Scheduled Weekly Hours

40

 

Employee Type

Regular

 

Work Shift

Day (United States of America)

 

Pay Range

$63,252.80 - $102,596.00/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 of