Project Manager 40 Hours Day Bwh - Cardiovascular Medicine
Project Manager 40 Hours Day Bwh - Cardiovascular Medicine
Posted on :
09-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
09-04-2025
Job Description
GENERAL SUMMARY/ OVERVIEW STATEMENT:
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.
Responsible for all aspects of project management and administration of several multicenter national and international clinical trials. The Project Manager is responsible for the startup and daytoday operations of all assigned ongoing clinical trials. This position has complete responsibility for meeting all deadlines and the complicated reporting requirements of the various sponsors including serious adverse event reporting and for ensuring all regulatory requirements are met in all countries for each ongoing clinical trial. This position is also responsible for the overall management of the TRG and for assisting the TRG Director with tasks as assigned.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
RESEARCH
1. In collaboration with the Director TRG Principal Investigators and study sponsors establishes clinical procedures and recruitment strategies and oversees the conduct of each clinical trial.
2. Is knowledgeable of all aspects of each trial to be able to evaluate questions and problems. Triages items to individuals with resources available to solve problems or answer questions.
3. Directs persons involved in daily tasks performed in the Directors Office to ensure smooth and efficient operations. These persons include research assistants/coordinators research administrator and administrative assistants in the Directors Office.
4. Independently designs and implements an action plan to identify and initiate clinical centers responsible for patient enrollment.
5. Actively assists recruitment efforts by writing educational materials and articles delivering presentations about the trial and educating physicians as potential referral sources.
6. Assists Director in the design of case report forms to capture necessary information to reach goals of the trials. Creates standardized definitions for each variable on the case report forms. Assists Director in redesign of case report forms as a result of study design change or amendment.
7. Designs and updates Manuals of Operation for each clinical trial. Provides detailed descriptions of how to perform tests and procedures and data management items.
8. Identifies organizes and ensures accurate completion of required regulatory documents from clinical centers (domestic and international) as necessary to perform the trials.
9. Works with sponsors on an ongoing basis to ensure that sufficient supplies are available to complete trials.
10. Develops an internal organizational structure to meet the needs of each study. This includes efficient distribution of information on a timely basis to clinical centers and core units.
11. Monitors progress of ongoing trials on a weekly basis. Interprets weekly statistics on patient enrollment case report form submissions delinquency reports and edit reports. Develops action plan to address problem centers.
12. Provides onsite advice to ensure protocol adherence if called on Hotline or asked by data coordinating center sponsor or research personnel at each participating hospital.
13. Prepares correspondence to study investigators as requested by Director.
14. Prepares newsletters which highlight important issues and updates study personnel on study progress.
15. Participates in all conference calls and all studyrelated meetings. Prepares agenda and minutes. Ensures all supportive documentation is available to persons participating in call.
16. Monitors expenditures of each trial as it progresses. Suggests modifications in expenditures as necessary or as directed by Director.
17. Negotiates modifications to budget with sponsor.
18. Oversees all financial aspects of TRG which includes: invoicing sponsors monitoring all active accounts for discrepancies running monthly finance meeting with Cardiovascular Division staff resolving any outstanding issues monitoring personnel salaries.
19. Maintains department service standards with particular attention to personal/behavioral staff teamwork and customerstaff interaction guidelines.
20. Performs other tasks and responsibilities are directed by the Director.
EDUCATION:
1.Independently plans and organizes two large educational events with over 40 speakers and 300 international and domestic attendees.
2.Develops and maintains a comprehensive budget for each educational event.
3.Works closely with Course Directors to develop content and schedule.
4.Negotiates contract with hotel.
5.Acts as main point of contact for all vendors used (hotel AV printer)
6.Develops a comprehensive marketing plan.
7.Ensure all deadlines are met.
ADMINISTRATIVE TASKS:
1.Assist a seniorlevel physician with administrative tasks as needed (i.e. booking travel updating CV).
2.Responsible for ensuring both the research office and clinical office are in good working order.
Day Shift
QUALIFICATIONS:
1. Minimum of Bachelors degree Masters degree preferred and experience in a health/researchrelated field.
2. Minimum of five years progressively responsible related experience preferably in healthcare managing all aspects of a busy research office.
3. Experience with computers and data management systems.
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 TRG 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. Ability to travel nationally and internationally on short notice.
WORKING CONDITIONS:
Clinical/research office environment with extended hours as needed to meet project deadlines
SUPERVISORY RESPONSIBILITIES:
Supervises research assistants(s)/coordinator(s) and TRG Fellow(s)/resident(s).
FISCAL RESPONSIBILITY:
In conjunction with Director the Project Manager is responsible for oversight of all TRG accounts.
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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