Project Manager Timi BWH Cardiovascular

General Summary

Working directly with the Sr. Director/Director, this position has complete responsibility for the day to day operational project management of assigned department/trial(s) within the TIMI Study Group. The TIMI Study Group is an Academic Research Organization whose principal goal is to conduct high quality multi-center, national and international clinical trials that enhance the care of patients with coronary artery disease.

Principal Duties

1. In collaboration with the Sr. Director, Director, TIMI Principal Investigators, and Study Sponsors, establishes, maintains and complies with policies and procedures for assigned department/trial(

2. Manage 1-2 global CV outcomes trials that typically involve ~10,000 patients enrolled at >500 sites in >30 countries and then with follow up for 5 years.

3. Manage International Steering Committee, Data Monitoring Committee and Clinical Events Committee.

4. Is knowledgeable of all aspects of assigned department/trial(s) to be able to evaluate questions and problems. Triages items to individuals with resources available to solve problems or answer questions.

1. Directs internal staff involved in daily tasks performed in the TIMI Study Group to ensure smooth and efficient operations. Works with Sr. Director/Director in hiring, training, and evaluation of assigned support staff.

2. Actively assists Sr. Director/Director by writing, memos, educational materials, newsletters, and articles. Creates presentations related to departmental/trial goals, strategies and outcomes.

3. Assists Sr. Director/Director in the design of reporting tools to capture necessary information to reach goals of the department/trials. Assists in re-design of reporting tools as a result of study design change or amendment.

4. Designs and updates Manuals of Operation for assigned department/trial(s).

5. Participates in internal and external audits.

6. Identifies, organizes, and ensures accurate completion and retention of required departmental/ trial(s) regulatory documents and other relevant files.

7. Keeps Sr. Director/Director informed of all issues, solutions and results by monitoring progress of departmental/trial(s) metrics on a regular basis. Must be able to interpret weekly report statistics, develop and implement action plans to address concerns when necessary.

8. Liaise with external vendors and/or related parties as a department/trial(s) representative to ensure smooth management of department/trial(s).

9. Participates in conference calls and departmental/trial(s) related meetings, presentations and trainings as requested. Prepares agenda and minutes. Ensures all supportive documentation is available to participants.

10. Prepares presentations for the three annual scientific cardiology sessions and investigator meetings.

11. Monitors expenditures and suggests modifications in expenditures as necessary or as directed by Sr. Director/Director.

12. Demonstrate and maintains high level of knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trials(s)

13. Maintains department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines.

14. Performs other tasks and responsibilities as directed.

Qualifications

1. Minimum of Bachelor's degree and experience in a health/research-related field.

2. Minimum of 5 years of progressively more responsible research work experience

3. Experience with computers and data management system

4. Supervisory Experience required

5. Clinical Trial Certification Preferred

Skills

1. Ability to accept a high degree of authority and responsibility for major decision-making as it relates to the conduct of large domestic and international clinical trials.
2. Excellent judgment and ability to interpret information and protocol requirements, and initiate appropriate actions given competing priorities.
3. Outstanding interpersonal and leadership skills to effectively interact with research coordinators, principal investigators, and to represent TIMI Study Group to sponsors and regulatory authorities (domestic and international).
4. Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds, and to function effectively as a member of a research team.
5. Outstanding organizational abilities to formulate and complete rigorous timetables.
6. Strong presentation skills.
7. Busy office environment with frequent deadlines
8. In conjunction with Sr. Director and Director supervises support staff of 2 to 10 individuals.
9. In conjunction with Sr. Director and Director is responsible for oversight of the assigned trial or department budget.

EEO Statement

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.