Centricity Research Looking for Contracts & Budgets Manager at Toronto, Ontario, Canada Full Time

Job Description

Position Title:

Contracts and Budgets Manager

Department:

Contracts and Budgets

Reports To:

Director, Study Administration

Direct Reports:

Contracts and Budgets Specialists, Study Support Analysts and Study Support Specialists

POSITION FUNCTION

The Contracts and Budgets Manager is responsible for the oversight of operations of the Contracts and Budgets Department which includes tasks such as preparing, maintaining, and negotiating budgets related to clinical trial activities as well as reviewing clinical trial contracts for routine changes and negotiating Clinical Trial Agreements (CTAs) with sponsors. The Contracts and Budgets Department also maintains all aspects of CTMS financial back-end administration data entry for all research studies.

Key metrics related to study start up timing will be monitored to ensure timely and accurate completion of documents to achieve efficient start up timelines and ensure partnership obligations are achieved.

Organization Summary

Our Passionate Cause:

Revolutionizing Research & Changing Lives!

Organization Profile:

Centricity Research is a clinical research organization with more than 40 sites, access to over 1.6 million patients and participants, and more than 150 active investigators across Canada and the southeastern United States. Our name, Centricity Research, was purposefully chosen to signify the fact that we are customer centric. Our study participants, sponsors, CROs, and physicians are the cornerstone of our business. The name Centricity Research also highlights the fact that our organization has earned a position of prominence and importance within the industry. We aim to build and nurture strong, trusting relationships with all audiences, and being customer-centric is embedded within our company culture.

FUNdamentals:

Centricity Research recognizes the following core values as being essential characteristics for individual and collective success:

• Dream Big
• Go Above and Beyond
• Do The Right Thing
• Be Curious
• Have Fun

Essential Functions

• Accountable to manage and supervise all activities necessary to ensure Contracts and Budgets department is efficient and competitive in relation to premiums and timelines
• Responsible for management duties as it relates to Contracts and Budgets personnel and/or volunteers/interns within the department
• Liaise with Regulatory team, Business Development team, Finance team and Senior Research Management as needed
• Requests clinical budget and contact documents from Sponsor/CRO
• Prepares, maintains, and negotiates budgets and prices to be charged by the company for clinical trial activities
• Coordinates with Finance department to provide analytics on average visit/pass through payments by Therapeutic Area and by Sponsor/CRO
• Reviews clinical trial protocols & develops internal budgets for final sign off from Principal Investigators & Senior Leadership
• Examines budget estimates for completeness, accuracy, and to assure conformance with trial protocol
• Reviews clinical trial contracts for routine changes and negotiates Clinical Trial Agreements (CTA) language with Sponsors/CROs
• Evaluates all legal and budgetary issues that may not be covered in the draft Clinical Trial Agreement (CTA) or budget
• Coordinates the budget process by providing data, information, and expertise to Leadership for the use in decision making and budget formulation
• Ensures that budget adjustments are made in accordance with legal and program requirements
• Reviews contractual documents on a highly time-sensitive basis and assists in the coordination of the signature process and assures appropriate filing/tracking
• Reviews consent form for event of injury language as well as examine cost section language against the contract and budget to ensure congruency
• Builds out visit templates in Clinical Trial Management System (CTMS) for current and upcoming research studies
• Ensures that the visits built in the CTMS can be completed accurately for the clinical team
• Enters all additional invoiceable CTA items into the CTMS to assist the finance team with billing the Sponsor/CRO
• Works with the Study Start-up team to ensure timely enrollment open for all new studies
• Creates and executes Statement of Works (SOWs) to determine contractor’s payment rate based on the Investigator’s specialty rate, number of visits expected, and the per patient budget (includes SIV, COV, and IMV payments).
• Drafts and executes Research Service Agreements (RSA) for new physicians.
• Reviews operating expense and revenue budgets to analyze trends affecting budget needs
• Maintains clinical budget and contract checklist in appropriate database
• Identifies and analyzes methods, policies, or programs that will lower costs or increase revenue
• Consistently maintains general knowledge of protocols and prepares amendments of budget and/or contracts as required by sponsors or as requested by principal investigators.
• Organizes the processing of study feasibility questionnaires and prepare budgets as necessary.
• Other duties and responsibilities as assigned.

Education/Experience

Minimum:

• 5 years-experience in clinical research, vast knowledge of Contracts and Budget negotiation is a requirement.
• High School Diploma/GED

Preferred:

• Bachelor of Science Degree
• 5 years-experience in clinical research Contracts and Budgets negotiation

Core Competencies/Skills

Prerequisite (Essential):

• Excellent communication skills (verbal and written)
• Excellent computer skills (MS Word, Excel and Outlook)
• Attention to detail
• Ability to manage time efficiently
• Self-directed
• Teamwork & Collaboration
• Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
• Flexible & Adaptable
• Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Foundation:

• Conflict resolution
• Receptive to feedback
• Empowering & Developing others
• Empathy Skills
• Planning and organizing skills
• Excellent problem-solving skills
• Achievement oriented
• Analytical ability
• Initiative
• Decision making

Leadership:

• Forward thinking
• Innovative
• Creative
• Strategic thinking
• Self confidence
• Strong interpersonal skills

PHYSICAL DEMANDS

• Physical demands include but not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
• Frequently required to complete work on the computer in a seated position.
• May be required to lift light boxes (10 – 20lbs)

WORKING CONDITIONS

• Modern medical office environment or home office environment
• Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations
• Required to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations
• Some positions may require overnight/weekend hours

Benefits

• Opportunities to work with internationally renowned physicians
• Comprehensive health benefits, competitive salary
• RRSP or 401(k) contribution matching
• Continued opportunities for growth & development; yearly education allowance
• Paid holiday closures and employee appreciation days off

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