QUALIFICATIONS:
1. Minimum of Bachelors degree and experience in a health/researchrelated field.
2. 4 to 5 years of Industry (domestic/international clinical trials) and/or Relevant Exp with a minimum 3 yrs at exempt level
3. Experience with computers and data management systems
4. Supervisory Experience
5. Clinical Trial Certification Preferred
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
1. Ability to accept a high degree of authority and responsibility for major decisionmaking 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.
WORKING CONDITIONS:
Busy office environment with frequent deadlines
SUPERVISORY RESPONSIBILITIES:
In conjunction with Sr. Director and Director supervises support staff of 2 to 10 individuals.
FISCAL RESPONSIBILITY:
In conjunction with Sr. Director and Director is responsible for oversight of the assigned trial or department budget.
GENERAL SUMMARY/ OVERVIEW STATEMENT:
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 multicenter national and international clinical trials that enhance the care of patients with coronary artery disease.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
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(s).
2. 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.
3. 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.
4. Actively assists Sr. Director/Director by writing memos educational materials newsletters and articles. Creates presentations related to departmental/trial goals strategies and outcomes.
5. Assists Sr. Director/Director in the design of reporting tools to capture necessary information to reach goals of the department/trials. Assists in redesign of reporting tools as a result of study design change or amendment.
6. Designs and updates Manuals of Operation for assigned department/trial(s).
7. Participates in internal and external audits.
8. Identifies organizes and ensures accurate completion and retention of required departmental/ trial(s) regulatory documents and other relevant files.
9. 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.
10. Liaise with external vendors and/or related parties as a department/trial(s) representative to ensure smooth management of department/trial(s).
11. 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.
12. Monitors expenditures and suggests modifications in expenditures as necessary or as directed by Sr. Director/Director.
13. Demonstrate and maintains high level of knowledge of regulations clinical research conduct laws guidelines and standards relating to department/trials(s)
14. Maintains department service standards with particular attention to personal/behavioral staff teamwork and customerstaff interaction guidelines.
15. Performs other tasks and responsibilities as directed.
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race sex color religion national origin sexual orientation protected veteran status or on the basis of disability.