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Clinical Contracts Associate - I
Job ID: 23-01395
Please review the job description below and advise if you would like to explore it further. We may have other jobs available as well which we can discuss once we connect.Job Title: Associate, Clinical Operations, Site Contracts & Site Onboarding
Duration: 18+ months, 40 hrs / week
Location: Remote
Pay Rate: $30 - $ 39.60 Hourly, All-inclusive
Job Description:
Job Title: Associate, Clinical Operations, Site Contracts & Site Onboarding
Location: Hybrid (2 days onsite) or Remote
Position will be accountable for the drafting, negotiation, and review of global Phase I through IV clinical investigative site and related ancillary contracts (together referred to as “site contracts”), including both language and budget, the management of Functional Service Providers (FSPs) involved in the contracting process. Position will also be responsible for all activities required from onboarding site and other suppliers into Gilead systems to appropriately set up the supplier for payment. Will require oversight of contract activities for multiple clinical development programs within the various Gilead therapeutic areas, ensuring the FSP provides adequate level of staff to complete contracts in an accurate, consistent, and timely manner. Must coordinate with the FSPs, Gilead Study Teams and Gilead Legal departments to manage and complete the site contract process throughout study duration. Responds and resolves complex issues associated with domestic and international contracts with support from more senior staff and Gilead Legal department. Ideal candidate will have demonstrated success in working collaboratively with stakeholders, especially senior Clinical Operations management.
• This role can manage the day-today activities in complex clinical trials contracts (CTA) and budget negotiation processes.
• Manages investigator payment supplier set up activities for multiple clinical development indications
• Focuses on site clinical trials contracting, fair market value (FMV) compliance of site contracts, compliance of supplier set up and accountability as it relates to FSP management and site start-up.
• Works with Functional Service Provider (FSP) to implement Site Contracts CALM Contracts Process to ensure efficient delivery of fully executed contracts.
• Manages the day-to-day activities of multiple areas in moderately complex clinical contracts and finance. Including but not limited working closely with internal clinical operations as it related to rapid study sites.
• Support management in identification of risks, develop mitigation strategies, alternative solutions, resolve issues, action item/follow up in collaboration with cross functional and/or matrix teams
• Assess project performance to monitor the progress of projects, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
• Ensure documentation and validation practices are consistent with company policies
• Assess knowledge and/or quality gaps of team to determine and deploy appropriate training plans and/or needs in collaboration with management
• Review, develop and manage workflow and work process standards to ensure that site onboarding activities comply with regulatory and business conduct requirements
• Develop and maintain department process guidance, training materials, and quality documents.
• Facilitate accurate and on time payment, investigator payment administration, Sunshine Act Compliance, and customer service to internal and external stakeholders including the clinical operations teams and investigators.
• Works with internal stakeholders in establishing payment arrangements for each clinical trial. Coordination and interaction include interface with Development and Information Systems, Data Management, Legal/Business Conduct and Accounts Payable.
• Partner closely with business users and EBS IT on the specification, documentation, validation, and implementation of payments systems and optimization projects.
• Evaluates contract and budget changes requested within CTA and identifies business and/or legal risks manage the issue to resolution by proposing and providing alternative solutions to legal or senior management.
• Identifies issues/problems and provides recommendations for solutions.
• Demonstrates ability to make critical decisions related to projects and tasks.
• Demonstrates ability to work in fast paced and changing environment
• Assists other staff in resolving moderately complex issues relating to contract negotiation and management.
• Ability to develop use spreadsheets and tracking tools.
• Leads the contract life cycle management process for assigned Clinical Trial Study.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates strong understanding of regulatory and legal issues pertinent to clinical trials and clinical site payments.
• This role must be able to interact on high level with the clinical teams, and project management to provide oversight of negotiations of CTA and clinical budgets.
• Completes tasks and projects under minimal to no supervision.
Knowledge, Experience and Skills:
• 4+ years of experience with a BA in a relevant discipline.
• 3+ years of experience with a MS/MBA in a relevant discipline.
• Relevant experience typically includes contract negotiation and/clinical finance
• Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
• Relevant experience typically includes contract language and budget negotiation, and application of project management principles.
• Global Site Contracting experience a plus.
• Skilled at project management, able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.
• Demonstrates patience and is able to break down complex information into digestible pieces.
• Able to work in a rapidly changing environment with a high tolerance for ambiguity.
• Aptitude to thrive in a fast-paced, changing environment while producing quality work under time constraint.
• Ability to analyze situations from organizational, departmental perspective (ie considers strategy, culture, structure, systems, people, processes and planning).
• Ability to work effectively in a team environment and creatively solve problems.
• Must exhibit a positive attitude, a respect for others, a results-oriented approach and ability to work independently as well as collectively.-----------------------------------------------------------------------------------------------------------------------------------------------------------
Job Title: Associate, Clinical Operations, Site Contracts & Site Onboarding
Location: Hybrid (2 days onsite) or Remote
Position will be accountable for the drafting, negotiation, and review of global Phase I through IV clinical investigative site and related ancillary contracts (together referred to as “site contracts”), including both language and budget, the management of Functional Service Providers (FSPs) involved in the contracting process. Position will also be responsible for all activities required from onboarding site and other suppliers into Gilead systems to appropriately set up the supplier for payment. Will require oversight of contract activities for multiple clinical development programs within the various Gilead therapeutic areas, ensuring the FSP provides adequate level of staff to complete contracts in an accurate, consistent, and timely manner. Must coordinate with the FSPs, Gilead Study Teams and Gilead Legal departments to manage and complete the site contract process throughout study duration. Responds and resolves complex issues associated with domestic and international contracts with support from more senior staff and Gilead Legal department. Ideal candidate will have demonstrated success in working collaboratively with stakeholders, especially senior Clinical Operations management.
• This role can manage the day-today activities in complex clinical trials contracts (CTA) and budget negotiation processes.
• Manages investigator payment supplier set up activities for multiple clinical development indications
• Focuses on site clinical trials contracting, fair market value (FMV) compliance of site contracts, compliance of supplier set up and accountability as it relates to FSP management and site start-up.
• Works with Functional Service Provider (FSP) to implement Site Contracts CALM Contracts Process to ensure efficient delivery of fully executed contracts.
• Manages the day-to-day activities of multiple areas in moderately complex clinical contracts and finance. Including but not limited working closely with internal clinical operations as it related to rapid study sites.
• Support management in identification of risks, develop mitigation strategies, alternative solutions, resolve issues, action item/follow up in collaboration with cross functional and/or matrix teams
• Assess project performance to monitor the progress of projects, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
• Ensure documentation and validation practices are consistent with company policies
• Assess knowledge and/or quality gaps of team to determine and deploy appropriate training plans and/or needs in collaboration with management
• Review, develop and manage workflow and work process standards to ensure that site onboarding activities comply with regulatory and business conduct requirements
• Develop and maintain department process guidance, training materials, and quality documents.
• Facilitate accurate and on time payment, investigator payment administration, Sunshine Act Compliance, and customer service to internal and external stakeholders including the clinical operations teams and investigators.
• Works with internal stakeholders in establishing payment arrangements for each clinical trial. Coordination and interaction include interface with Development and Information Systems, Data Management, Legal/Business Conduct and Accounts Payable.
• Partner closely with business users and EBS IT on the specification, documentation, validation, and implementation of payments systems and optimization projects.
• Evaluates contract and budget changes requested within CTA and identifies business and/or legal risks manage the issue to resolution by proposing and providing alternative solutions to legal or senior management.
• Identifies issues/problems and provides recommendations for solutions.
• Demonstrates ability to make critical decisions related to projects and tasks.
• Demonstrates ability to work in fast paced and changing environment
• Assists other staff in resolving moderately complex issues relating to contract negotiation and management.
• Ability to develop use spreadsheets and tracking tools.
• Leads the contract life cycle management process for assigned Clinical Trial Study.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates strong understanding of regulatory and legal issues pertinent to clinical trials and clinical site payments.
• This role must be able to interact on high level with the clinical teams, and project management to provide oversight of negotiations of CTA and clinical budgets.
• Completes tasks and projects under minimal to no supervision.
Knowledge, Experience and Skills:
• 4+ years of experience with a BA in a relevant discipline.
• 3+ years of experience with a MS/MBA in a relevant discipline.
• Relevant experience typically includes contract negotiation and/clinical finance
• Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
• Relevant experience typically includes contract language and budget negotiation, and application of project management principles.
• Global Site Contracting experience a plus.
• Skilled at project management, able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.
• Demonstrates patience and is able to break down complex information into digestible pieces.
• Able to work in a rapidly changing environment with a high tolerance for ambiguity.
• Aptitude to thrive in a fast-paced, changing environment while producing quality work under time constraint.
• Ability to analyze situations from organizational, departmental perspective (ie considers strategy, culture, structure, systems, people, processes and planning).
• Ability to work effectively in a team environment and creatively solve problems.
• Must exhibit a positive attitude, a respect for others, a results-oriented approach and ability to work independently as well as collectively.-----------------------------------------------------------------------------------------------------------------------------------------------------------
Intelliswift is committed to fair and equitable compensation practices. The range provided for this position is determined by various factors including, but not limited to, relevant work experience, skills, certifications, and location. Intelliswift offers medical insurance, dental insurance, vision insurance, supplemental life and AD&D insurance, and any other benefits per state law.
Equal Employment Opportunity Statement
Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.
Americans with Disabilities Act (ADA)
If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department
Other Employment Statements
Intelliswift participates in the E-Verify program.
For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.
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