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Program Manager, Office of Clinical Trials Management (SOM Stratford)

Rowan University
New Jersey, United States
Salary Not Specified
Posted date
Jul 30, 2021

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Position Type
Faculty Positions, Health & Medicine, Medicine, Administrative, Academic Affairs, Other Academic Affairs, Business & Administrative Affairs, Other Business & Administrative Affairs, Grants & Contracts
Employment Type
Full Time
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Job Title: Program Manager

Department: Office of Clinical Trials Management

Facility: School of Osteopathic Medicine

Reports To: Senior Associate Dean for Research

SUMMARY: Reporting to the Sr, Associate Dean for Research, the Program Manager plans, organizes and manages clinical trials, typically Phase III and IV, across several therapeutic areas and maintains proficient knowledge of regulations, requirements, and current trends in Phase WIV trials. The responsibilities include but are not limited to, assisting in application preparation for new studies, managing budgets and resources for studies, directing and mentoring staff, and assuring the satisfaction of clients, investigators, patients and service partners; directing and managing educational and research activities; and supervising clerical, technical and professional staff. Provides services to off-site faculty practices.

ESSENTIAL Duties AND RESPONSIBILITIES include the following:

Identifies all departmental staffing needs, helps to select, trains, supervises, and evaluates, professional staff. Orientates and ensures the integration of new staff members into the department and work units

Assures efficient staffing, develops and administers departmental programs and policies that contribute to the recruitment, retention, motivation and development of staffing at all levels.

Manages Clinical Study Coordinators across the Stratford campus as well as provides internal management and consultative services to the professional staff, program directors and faculty, with respect to planning, developing and carrying out proposals and objectives.

Responsible for the overall management of the investigative sites, and assists the Investigator, as well as the pharmaceutical companies, in the processing of regulatory documents to ensure site is conducting trials under ICH/GCP Guidelines, Trains staff and assures that all regulatory requirements are met for all of the regulatory standards ICH/GCP and human protection regulations, Interfaces with the University and Western-Copernicus RBs for initial IRB submissions, modifications adverse event reporting and closeouts.

Coordinates the efforts of the other departments involved with the clinical trial process to ensure that all aspects of the project, as defined in the protocol and contract, are occurring on schedule.

Responsible for contract negotiations and submission of Clinical Trial Agreement and related subcontracts, negotiates budgets.

Coordinates and contributes to project development meetings, and reviews contract, protocol, and case report forms for the project, study document development and study closeout activities.

Function as liaison between the sponsor and the project team, prepare for external audits, manage/host monitoring visits, respond to data queries, report adverse events and manage test article accountability.

Manages recruitment, study subject visits, schedules, sample collection and shipping samples.

Manages the development of the project teams, including members of the medical, data management, regulatory monitoring and clinical supplies departments, as needed, and assures that all project tasks are performed per departmental standard operating procedures.

May help represent the department at meetings of national, state and local organizations to advance the department) s programs, activities and roles in the healthcare field

Plays an instrumental role in the development of new standard operating procedures, revision and update of current standard operating procedures.

Manages communication with and within all departments regarding the delegation of study tasks and teams, and provides direction for study issues resolution,

Provides overall monthly project status reports, per sponsor requirements, and assists in the preparation of budgets as well as budget revisions.

Provides monthly update on clinical trial revenue and clinical trials activity to Sr, Associate Dean for Research.

Helps to ensure Clinical Trials Office meets its yearly goals,

Develops and maintains sound working relationship with various areas of the University, such as Purchasing, Human Resources, Budgets and Operations, and seeks appropriate advice and counsel from these departments, as required.

Acts as a role model for customer service and improved quality,

Supports the University's goal on workplace diversity and EEO goals and objectives concerning employment and promotional opportunities.

Understands and adheres to Rowan University's compliance standards as they appear in RowanSOM's Corporate Compliance Policy, Code of Conduct and Conflict of Interest Policy,

Keeps abreast of all federal, state and University regulations, laws and policies as they presently exist and as they change or are modified,

Ensures that staff are trained and evaluated on their knowledge of and adherence to compliance policies and procedures specific to their jobs.

Performs other related duties as assigned.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE: Bachelor Degree, RN preferred, plus five (5) years experience including clinical trial experience and trial planning, including development of study logistics timelines, budgets, investigational site recruiting and experience working with clinical trial data. Effective oral and written communication skills and ability to deliver high-quality results with aggressive timelines; and knowledge of FDA regulatory requirements, Outstanding human relations and leadership skills, and the ability to function in a team environment are required. Demonstrated knowledge of how to accomplish superior performance in a unionized environment is necessary. Equivalent education, experience and/or training may be substituted for the degree requirements.

Candidates must be legally authorized to work in the US, and the university will not sponsor an applicant for a work visa for this position.

Advertised: Jul 30 2021 Eastern Daylight Time
Applications close: Sep 3 2021 11:55 PM Eastern Daylight Time

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