Clinical Trial Lead CVD TIMI
Apply NowCompany: Mass General Brigham
Location: Boston, MA 02115
Description:
Site: The Brigham and Women's Hospital, Inc.
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
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.
Essential Functions
-Manage multiple clinical trial sites for the duration of the trial.
-Collect and review site's essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval.
-Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
-Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
-Contribute to the identification and implementation of process improvement opportunities.
-Assist in the training and development of other junior staff members in key processes and procedures.
-Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
-Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
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 (domestic/international clinical trials) 3-5 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.
- Ability to work independently and display initiative.
- Detail-oriented and strong organizational skills.
- Ability to communicate effectively in a matrix environment.
- Strong sense of accountability and an ability to work autonomously, as well as act as a strong team player.
- Solid written and verbal communication skills.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
350 Longwood Avenue
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement:
The Brigham and Women's Hospital, Inc. 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 Veteran's 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 (857)-282-7642.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
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
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.
Essential Functions
-Manage multiple clinical trial sites for the duration of the trial.
-Collect and review site's essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval.
-Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
-Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
-Contribute to the identification and implementation of process improvement opportunities.
-Assist in the training and development of other junior staff members in key processes and procedures.
-Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
-Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
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 (domestic/international clinical trials) 3-5 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.
- Ability to work independently and display initiative.
- Detail-oriented and strong organizational skills.
- Ability to communicate effectively in a matrix environment.
- Strong sense of accountability and an ability to work autonomously, as well as act as a strong team player.
- Solid written and verbal communication skills.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
350 Longwood Avenue
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement:
The Brigham and Women's Hospital, Inc. 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 Veteran's 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 (857)-282-7642.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.