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UNIV - Clinical Trial Finance Manager - Department of Medicine: Medicine Administration

Apply now Job no: 522964
Entity: MUSC University
Department: COLLEGE OF MEDICINE - COM-Dept of Medicine
Sub Department: UNIV-2220010-Medicine Administration
Work type: Full-Time
Employee Type: UNIV - Classified
Location: Charleston, SC-Downtown
Categories: Administrative & Non-Clinical Professionals
Pay scale: UNIV-Band 7: $49,594.00 - $70,674.00 - $91,755.00 (min - mid - max)

FLSA: Salaried

 

Job Summary: The Clinical Trial Financial Manager provides financial and administrative management for clinical trials managed and/or initiated by the faculty members in the Department of Medicine (DOM) from study development through study closure. These studies may include Industry Sponsored Trials, Investigator-Initiated Trials, Foundation awards and Federal Clinical Trials. Funding sources include industry, federal/non-federal grants, non-profit and philanthropy. This position will collaborate with the Office of Clinical Research to facilitate budget development from study initiation to study closure. This position is a core member of the DOM Leadership team and reports to the Director of Research Administration for the Department of Medicine.

Payscale Salary Range: UNIV-Band 7: $49,594.00 - $70,674.00 - $91,755.00 (min - mid - max)

Job Duties: 

  • 30% - • Manage the industry award post award process. • Manages and leads the establishment of new clinical trial projects in UMS and oversees the accurate and timely reconciliation of each project. • Determines % effort by each study coordinator on a trial and ensures effort is appropriately charged on PEAR forms. • Manages all departmental research recharge centers. • Approves all non-payroll expenses on all clinical trials. • Manages the timely reconciliation of earned income and submission of invoices. Directly responsible for ensuring all earned income is identified and received. • Manages and oversees the preparation and timely distribution of all PI reports for the 200+ industry contracts. • Meets regularly with PI’s, clinical research coordinators, division administrators and division analysts to ensure compliance with university and sponsor guidelines and to reduce risk of cost overruns. • Responsible for submitting No Cost extensions, federal carryover requests, contract amendments and other required documentation. • Works with Grants and Contracts Administration on timely close outs of all clinical trials; • Manages the reconciliation of closed trials and oversees disbursement of residual funds to the proper account. • Works in conjunction with Fiscal Analysts and Division Administrators to identify projects that can support PI effort and projects that are closing in either a deficit or residual to ensure each division is managing their projects effectively. • Updates the Departmental Grant End Dates report for assigned clinical trials monthly and submits this to the Department Research Administrator to track the status of each clinical trial. - (Essential)
  • 30% - • Serves as the pre-award clinical trial expert working with department leadership as the point of contact for all federal clinical trial subaward sites. Works with each external site to draft and submit the necessary documents needed for submission. • Manages the DOM Clinical Trial Pre-Award process of successfully submitting all federal, foundation and corporate clinical trials by overseeing and managing the proposal development and submission process. Over 70 proposals are submitted annually. • Researches relevant RFP / PA for potential funding opportunities. Works directly with faculty in proposal development; develops budgets and budget justifications in accordance with agency guidelines. • Determines potential fiscal issues such as cost allowability, cost sharing, F&A rates, possible request for waivers. • Manages budgets and negotiate budgets with industry sponsors; route and submit all required documentation. • Makes recommendations to PIs on the financial feasibility of a study and provides a break even analysis; reviews and approves all relevant documentation for the submission process including justifications, scope of work, biosketches, letters of support, and other supporting documentation; prepares all federal clinical trials for department and university approvals including routing and follow up. - (Essential)
  • 25% - • Directly manages the Industry and Federal Clinical Awards. Responsibilities include: continuously develops and updates policies and procedures for efficiency, accuracy and to create a uniform workflow; manages the Clinical Research portfolio for the Department of Medicine by overseeing the timeliness and accuracy of reconciliations, ensuring the receipt and proper posting of all earned income, tracking enrollment and burn rates, reviewing PI reports to ensure accuracy of spending and project balances. • Manages the subaward invoice email folder by forwarding invoices to the correct analyst or clinical trial team member, manages the subaward tracker sheet by ensuring invoices are being processed properly in Marketplace, and provides GCA with updates when needed. • Develops new practices as needed as clinical trials evolve and change and training as needed to division study coordinators, grants administrators and department grant administrators. • Responsible for developing and providing monthly clinical trial reports for each division’s budget-to-actual meetings and any other reporting to DOM Leadership as requested. • Provide input and guidance to Division Administrators and Post Award Accountants during the annual College of Medicine budgeting process as it relates to projecting industry sponsored MUCR revenues and expenses. - (Essential)
  • 15% - • Serves as an expert in the life cycle of clinical trial management for the Department of Medicine’s 14 Divisions. • Serves as a resource with Accountant/Fiscal Analysts on post award management as needed. • Serves as department expert who has strong understanding of ORSP/GCA and external agency policies and procedures Provides training to grant administrators as requested by leadership. • Supervises and the Clinical Trial Team employees and all divisional based grants coordinators focusing on all aspects of clinical trial management. Reviews employees work and meets regularly with employees to review tasks and responsibilities. • Leads the implementation of and management of the clinical trial management system (CTMS) in the Department of Medicine. • Implements and performs a quality control review of all grants coordinators to ensure compliance with policies. Provides regular f feedback to staff and management and implements corrective actions as needed. • Advises senior leadership (Chairman, Vice Chairs, Director of Research) regarding new regulatory, compliance and budgetary issues related to clinical trial management. • Reviews changes to policies quarterly and communicates changes to staff, Department Leadership, division grant administrators, study coordinators and PIs. • Provides regular feedback to staff and management and implements corrective actions as needed. - (Essential)

 

Preferred Experience & Additional Skills: 

  • A bachelor's degree in business administration, public administration or the social sciences and four years’ experience in contracts and grant administration activities required.
  • Candidate must have prior clinical research experience, and familiarity with clinical trial processes and all aspects of study conduct. Prior experience preparing/negotiating study budgets and/or managing financial aspects of clinical trials is preferred but not required.
  • Candidate must have prior experience with Federal and Foundation grant management. 
  • Master’s degree preferred

Minimum Experience and Training Requirements: A bachelor's degree in business administration, public administration or the social sciences and four years experience in contracts and grant administration activities.

Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to bend at the waist. (Frequent) Ability to fully use both hands/arms. (Continuous) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift, carry, lower, push or pull objects 15 lbs.or more, unassisted. (Frequent) Ability to maintain 20/40 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Continuous) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Continuous) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Frequent) Ability to hear and/or understand conversations. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

 

 

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.


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The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.