Contract Manager

CenExel•,

2d•Remote

About The Position

The Contract Manager ensures clinical trial agreements are negotiated in accordance with company standards and policies by managing site-level study budgeting and contracting. The role facilitates contract and budget negotiations with sponsors, CROs, and vendors, and works with internal and external stakeholders to address study start-up, legal, and budgetary challenges. The Contract Manager creates, negotiates, submits, and modifies study budgets; coordinates agreement execution and budget details across departments; prepares study budgets and financial viability assessments; and develops cost estimates for Business Development opportunities and RFPs. The role also reviews and finalizes study amendments and supports study feasibility and pre-study selection. It collaborates with Clinical Operations, Business Development, and Finance to support timely site start-up, including periodic travel to sites. The position may analyze contracting data to identify pricing and process improvements and prepares reports and data summaries for management. It also hires, trains, supervises, and evaluates personnel, and promotes adherence to applicable regulations, guidelines, protocols, SOPs, and company policies. Other duties may be assigned.

Requirements

Bachelor's degree in finance, accounting, or a related field.
At least 5 years of experience in contract management, financial analysis, forecasting, general accounting, or comparable work.
Experience drafting, reviewing, and negotiating business contracts.
Strong analytical and negotiating skills.
Excellent written and verbal communication skills.
Highly organized and efficient, with the ability to handle multiple competing tasks.
Keen attention to detail.

Nice To Haves

Prior experience working within the clinical research industry.

Responsibilities

Facilitate study contract and budget negotiations for CenExel research sites with sponsors, CROs, and vendors as needed.
Work with internal and external stakeholders to manage or troubleshoot study start-up, legal, and budgetary challenges.
Comply with current protocols, SOPs, GCP, IRB, and FDA guidelines.
Create, negotiate, submit, and modify study budgets based on company requirements and legal guidance.
Communicate with sponsors and CROs through agreement execution and coordinate budget details with other departments.
Collaborate with Clinical Operations, Business Development, and Finance to support timely site start-up of new clinical trials, including periodic travel to sites.
Prepare budgets for new studies and evaluate the financial viability of studies.
Prepare cost estimates for Business Development opportunities and RFPs.
Review, negotiate, and finalize study amendments.
Provide support and recommendations for study feasibility and the pre-study selection process.
Analyze data, as needed, to identify trends and opportunities to improve contracting pricing and processes.
Assemble and summarize data and prepare reports for management as requested.
Hire, train, supervise, and evaluate personnel.
Champion and enforce adherence to best practices, FDA Code of Federal Regulations, ICH, GCP, CenExel SOPs, site Working Practices, protocols, and company guidelines and policies.
Retrain personnel and implement corrective and preventative actions as needed.
Assume other duties and responsibilities as assigned.