Overview
Salary Range:
$145,600 - $166,400 per year
Location:
Redwood City, CA - Hybrid Role
Job Summary We are seeking a highly motivated and detail-oriented individual to manage all aspects of Expanded Sponsored Research (ESR) contracts, including Investigator-Sponsored Trial (IST) agreements. The ESR Contract Manager plays a pivotal role in negotiating contracts and budgets aligned with protocol specifications, ensuring compliance with company regulatory and fair market value (FMV) standards. The contract manager will be responsible for maintaining tracking systems and overseeing investigator contracts and budgets. Additionally, responsible for the timely and accurate processing and administration of payments to the sites. This role is an individual contributor with team leadership responsibilities, reporting to the Director, Clinical Site Contracts.
Requirements and Qualifications
BS/BA degree in a related discipline and a minimum of seven years of related experience; or,
Develop clinical trial budgets according to protocol specifications.
Independently manage clinical trial contract/budget negotiations with sites.
Maintain a tracking system of all ESR(IST) agreements, issues, and communications with internal and external sources regarding contract and budget status.
Review and negotiate investigator-prepared budgets for FMV compliance.
Develop management reports to support budgeting and forecasting.
Maintain internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
Help foster good relationships with clinical investigators.
Responsible for reconciliations.
Participate in team meetings.
Ensure compliance with policies and procedures.
Contract amendments, and is responsible for developing work instructions, internal and external training, managing workload, and preparing and monitoring tracking systems.
Preferred Qualifications
Strong Excel knowledge required; GrantPlan experience.
Apply strong analytical and business communication skills.
Ability to work effectively in a team/matrix environment.
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
CMS experience.
Strong organization skills with knowledge in creating/managing spreadsheets.
Desired Skills and Experience Expanded Sponsored Research (ESR) contract management, Investigator-Sponsored Trial (IST) agreements, clinical trial contract negotiation, clinical trial budget development, protocol-based budgeting, fair market value (FMV) compliance, investigator budget review and negotiation, site contract negotiations, contract amendments, payment processing and site payments administration, contract and budget tracking systems, reconciliations, budgeting and forecasting, management reporting, compliance with regulatory requirements, policy and procedure adherence, cross-functional collaboration, Clinical Operations collaboration, Drug Safety collaboration, Legal and Medical Affairs coordination, investigator relationship management, workload management, work instruction development, internal and external training, team leadership, matrix team collaboration, analytical skills, business communication, Excel (advanced), spreadsheet development and management, GrantPlan, Smartsheet, CMS experience, oncology clinical trials, biotech/pharmaceutical industry experience
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.s CCPA Privacy Policy at www.baysidesolutions.com.
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$145,600 - $166,400 per year
Location:
Redwood City, CA - Hybrid Role
Job Summary We are seeking a highly motivated and detail-oriented individual to manage all aspects of Expanded Sponsored Research (ESR) contracts, including Investigator-Sponsored Trial (IST) agreements. The ESR Contract Manager plays a pivotal role in negotiating contracts and budgets aligned with protocol specifications, ensuring compliance with company regulatory and fair market value (FMV) standards. The contract manager will be responsible for maintaining tracking systems and overseeing investigator contracts and budgets. Additionally, responsible for the timely and accurate processing and administration of payments to the sites. This role is an individual contributor with team leadership responsibilities, reporting to the Director, Clinical Site Contracts.
Requirements and Qualifications
BS/BA degree in a related discipline and a minimum of seven years of related experience; or,
Develop clinical trial budgets according to protocol specifications.
Independently manage clinical trial contract/budget negotiations with sites.
Maintain a tracking system of all ESR(IST) agreements, issues, and communications with internal and external sources regarding contract and budget status.
Review and negotiate investigator-prepared budgets for FMV compliance.
Develop management reports to support budgeting and forecasting.
Maintain internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
Help foster good relationships with clinical investigators.
Responsible for reconciliations.
Participate in team meetings.
Ensure compliance with policies and procedures.
Contract amendments, and is responsible for developing work instructions, internal and external training, managing workload, and preparing and monitoring tracking systems.
Preferred Qualifications
Strong Excel knowledge required; GrantPlan experience.
Apply strong analytical and business communication skills.
Ability to work effectively in a team/matrix environment.
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
CMS experience.
Strong organization skills with knowledge in creating/managing spreadsheets.
Desired Skills and Experience Expanded Sponsored Research (ESR) contract management, Investigator-Sponsored Trial (IST) agreements, clinical trial contract negotiation, clinical trial budget development, protocol-based budgeting, fair market value (FMV) compliance, investigator budget review and negotiation, site contract negotiations, contract amendments, payment processing and site payments administration, contract and budget tracking systems, reconciliations, budgeting and forecasting, management reporting, compliance with regulatory requirements, policy and procedure adherence, cross-functional collaboration, Clinical Operations collaboration, Drug Safety collaboration, Legal and Medical Affairs coordination, investigator relationship management, workload management, work instruction development, internal and external training, team leadership, matrix team collaboration, analytical skills, business communication, Excel (advanced), spreadsheet development and management, GrantPlan, Smartsheet, CMS experience, oncology clinical trials, biotech/pharmaceutical industry experience
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.s CCPA Privacy Policy at www.baysidesolutions.com.
#J-18808-Ljbffr