Contract Manager

Socket.dev; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

CenExel Clinical Research is seeking a Contract Manager to ensure clinical trial agreements align with company standards by managing site budgets and contracting. The role collaborates with Sponsors, CROs, and vendors, ensuring adherence to FDA, GCP, and SOP guidelines and driving efficient contract workflows.

The ideal candidate has 5+ years in contract management within clinical research, strong negotiation and analytical skills, and the ability to lead cross-functional teams while maintaining

Qualifications

• Bachelor's degree in finance, accounting or related field.
• 5+ years minimum experience within contract management, financial analysis, forecasting, general accounting or comparable experience.
• Experience drafting, reviewing, and negotiating business contracts.
• Strong analytical and negotiating skills.
• Excellent communication skills, both written and verbal.
• Highly organized and efficient with ability to handle multiple competing tasks.
• Keen attention to detail.
• Prior experience working within the clinical research industry is a plus.

Responsibilities

• Facilitates study contract and budget negotiation for CenExel research sites with Sponsors, CROs, and vendors as needed.
• Works closely with internal and external stakeholders to manage or troubleshoot any study start up, legal, and budgetary challenges.
• Complies with current protocols, SOP's, GCP's, IRB, and FDA guidelines.
• Creates, negotiates, submits, and modifies study budgets based on company requirements and legal guidance.
• Communicates with sponsor, CRO's through execution of agreements and coordinates budget details with other departments as appropriate.
• Collaborates with Clinical Operations, Business Development and Finance in support of timely site start-up of new clinical trials including periodic travel to sites.
• Responsible for preparing budgets for new studies and evaluating financial viability of all studies.
• Prepares cost estimates for Business Development for opportunities / RFPs.
• Reviews, negotiates, and finalizes study amendments.
• Provides support and recommendations as needed with study feasibility and pre-study selection process.
• May analyze data to identify trends and area of improvements in contracting pricing and process.
• Provides information to management by assembling and summarizing data; preparing reports as requested.
• Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.

Skills

Negotiation

Analytical skills

Communication

Organization

Attention to detail

Education

Bachelor's degree in finance, accounting or related field

Job description

About Us:

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

The Contract Manager will be responsible for ensuring clinical trial agreements are negotiated in line with company standards and policies by managing site level study budgeting and contracting.

Essential Responsibilities and Duties:

• Facilitates study contract and budget negotiation for CenExel research sites with Sponsors, CROs, and vendors as needed.
• Works closely with internal and external stakeholders to manage or troubleshoot any study start up, legal, and budgetary challenges.
• Complies with current protocols, SOP's, GCP's, IRB, and FDA guidelines.
• Creates, negotiates, submits, and modifies study budgets based on company requirements and legal guidance.
• Communicates with sponsor, CRO's through execution of agreements and coordinates budget details with other departments as appropriate.
• Collaborates with Clinical Operations, Business Development and Finance in support of timely site start-up of new clinical trials including periodic travel to sites.
• Responsible for preparing budgets for new studies and evaluating financial viability of all studies.
• Prepares cost estimates for Business Development for opportunities / RFPs.
• Reviews, negotiates, and finalizes study amendments.
• Provides support and recommendations as needed with study feasibility and pre-study selection process.
• May analyze data to identify trends and area of improvements in contracting pricing and process.
• Provides information to management by assembling and summarizing data; preparing reports as requested.
• Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• Bachelor's degree in finance, accounting or related field.
• 5+ years minimum experience within contract management, financial analysis, forecasting, general accounting or comparable experience.
• Experience drafting, reviewing, and negotiating business contracts.
• Strong analytical and negotiating skills.
• Excellent communication skills, both written and verbal.
• Highly organized and efficient with ability to handle multiple competing tasks.
• Keen attention to detail.
• Prior experience working within the clinical research industry is a plus.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. Remote work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.