Director, Clinical Research Finance Operations

Panoramic Research is committed to improving patient outcomes, slowing disease progression, and enhancing patients' quality of life. Once of the ways we achieve this is by marrying clinical research with clinical implementation to redefine the standard of kidney care and keep people living with kidney disease healthier and longer. Our full-service support provides access to large, representative patient populations and our national platform of principle investigator and trail-ready sites, including ambulatory surgical centers.

To learn more about Panoramic Science visit: https://panoramichealth.com/clinical-research/

This position is fully remote, we are willing to consider candidates based on location.

Director, Clinical Research Finance Operations is responsible for overseeing all day to day, cross-functional operations of the research business. As a team leader, the Director, Clinical Research Finance Operations will ensure that all department functions and communications are performed in a timely manner, in compliance with Federal Regulations and within the terms of project contracts. The Director will insure that assigned studies are delivered successfully, on−time, within budget, according to client expectations and with the highest level of quality possible. The Director, Clinical Research Finance Operations may manage the following team employees: Clinical Project Managers, Site Development Managers, Financial Analysts, and oversee any combination of the following: single or limited services study or a small regional cross−functional study.

The Director Research Operations in concert with the Vice President of Clinical Research, is accountable for achieving successful delivery of clinical trial activities at the project level by meeting company and regulatory requirements according to time, quality/scope, budget, and contractual constraints. The Director, Clinical Research Finance Operations assists the Vice President of Clinical Research (VP) and or other company leadership in the development of research department operations and the conduct of clinical trials.

Responsibilities Include

• Proactively manages project level operational aspects of all active clinical trials; including adherence to contract, study timeline, enrollment targets, services and site budgets, resources, and vendors.
• Provides regular updates on trial progress to the VP and/or company leadership with respect to project plans, trial services and site budget, timeline management, quality standards and risk mitigation.
• Leads study startup process, including but not limited to, negotiation of COMPANY MSA, SoW, services budget, site budget, the set-up of clinical trial files for ongoing study management and tracking, site selection and finalization of site and vendor contracts and budgets, financial tracking tools.
• Ensures effective project plans are in place and operational for each trial and works proactively with COMPANY colleagues to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Ensures potential study risks are escalated to the attention of the VP when appropriate.
• Hosts working group and study status update meetings on a regular basis and ensures meeting minutes are completed, distributed to team members, and filed in the study file in a timely manner.
• Monitors compliance with all COMPANY policies, with particular attention to those regarding document collection at study start-up, Governing Body Approval, Medicare Flagging, review of site monitoring letters for quality issues and remedy of quality issues with the appropriate team member.
• Responsible for the development and deployment of all study specific and general research training for facility staff and research site staff.
• Ensures all project level study documentation and regulatory documents are filed in accordance with company SOPs and provides oversight to the clinical team regarding filing, maintenance, and archival procedures.
• Effectively provides support to Clinical Site Manager(s) and facility Managers in the conduct of the trials.
• Prepares timelines, budgets, and enrollment targets for all projects and ensures compliance to all reporting standards and timeframes.
• Responsible for determining when a change in scope is warranted and proceeds with contract and budget adjustments accordingly.
• Ensures timely payment of research related accounts receivable for COMPANY, and all payments made to COMPANY research sites.
• Participates in business development activities, as required, including but not limited to: reaching out to clinical trial sponsors and CROs, assisting with protocol feasibility and RFP responses.
• Proactively manages project budget, including scope and scope changes, budget versus actual costs, forecasting and margin evaluations.
• Oversees the financial activities of the project by recognizing the appropriate revenue and working with the Finance Department to ensure project accounting is accurate.
• Exercises appropriate supervisory responsibility for the research team. Responsibilities include working with the Vice President of Clinical Research to coordinate scheduling and delegation of work, interviewing, training and orientation of new staff, and performance evaluation and management.
• Perform other duties and responsibilities as required, assigned, or requested.
  
  
  

Qualifications

• Bachelor’s degree is required, advanced degree preferred.
• 7 years of research management experience preferred.
• Experience working on multiple large-scale clinical trials in nephrology, cardiology, or endocrinology.
• High degree of computer literacy. Experience with PowerPoint and Excel required.
• Working knowledge of clinical research protocols and Good Clinical Practice. Exposure to clinical and/or medical/psychological research preferred.
• Ability to work independently and with teams on complex problems and to develop resolutions at both strategic and functional level.
• Ability to define project scope, set clear goals and expectations, prioritize activities, set milestones, and follow through to successful completion.
• Excellent interpersonal skills including communication, negotiation, problem resolution, and customer service.
• Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
  
  
  

The Company is committed to the principles of equal employment. We are committed to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment which is free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other status protected by federal, state, or local laws. The company is dedicated to the fulfillment of this policy in regard to all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment

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