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- Manager, Clinical Trial Agreements
Description
The COG Research Foundation, LLC, is seeking a proactive, detail-oriented, and skilled contracting professional for an inaugural position of Manager, Clinical Trial Agreements (internally referred to as Manager, Industry Contracts). The Contracts Management department supports contracts for clinical trial research, agreements for multi-sited activities, as well as non-monetary agreements such as memoranda of understanding for collaborations, data use agreements, material transfer agreements, and confidentiality agreements. The position is responsible for administering the drafting, negotiation and execution of the full suite of contracts and agreements related to, primarily, industry-funded clinical research in a dynamic, quickly evolving new Contracts Management department. This role ensures that all contracts and agreements in the Manager’s portfolio comply with institutional policies, the industry entities’ terms and conditions, National Cancer Institute’s requirements and guidelines, and all applicable laws, and regulations, while effectively managing risk and fostering strong relationships with internal and external stakeholders. Responsibilities include administering and negotiating complex agreements with industry entities, research sites, and vendors.
In addition, the individual holding this position will also be responsible for collaborating with the Associate Director and Senior Director of the department to implement the Contracts Library Management (CLM) system for the Contracts Management department. Thereafter, this position will assist in the day-to-day administration of the CLM system. The Manager will report to the Associate Director of Contracts Management, providing additional strategic input, vision and facilitation for the department’s contracts management functions.
We are looking for a professional with a strategic mindset, and the ability to administer a sizable portfolio of, primarily, industry related clinical research agreements, strong negotiation skills, and the ability to prioritize their workload under challenging timelines with minimal oversight. The ideal candidate will have solid experience administering, reviewing and negotiating through to execution complex industry sponsored/supported clinical trial agreements, clinical research support agreements, and subagreements, all while promoting an ethical culture of accountability, compliance, and ensuring alignment with organizational goals and external requirements. The successful candidate should also have demonstrated experience in monitoring agreements and initiatives and maximizing key metrics and effectively communicating these across multiple departments to support leadership.
The individual should be proficient and comfortable with research administration and contracting systems implementation, stakeholder engagement, change management, and policy alignment, and demonstrate strong process-mapping and documentation skills critically when operationalizing Contract Lifecycle Management (CLM) workflows.
This is an ideal position for an experienced mission-driven contracts professional who is passionate about the mission and eager to contribute to lasting change. The Children’s Oncology Group is a 100% remote employer, though some travel may be required. Employee must reside within the United States.
Full salary range for this position: $91,910 to $137,348 per year. The typical hiring range for this position is from $91,910 (minimum) to $114,629 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.
Key Responsibilities:
Primarily Industry Supported Contracts Administration
- Administer a portfolio of, primarily, industry-supported agreements within the Contracts Management department, including the day-to-day functions related to and involving review and negotiation of such agreements under the direction of the Associate Director of Contracts Management.
- Interface with internal and external stakeholders to successfully perform the administration of and day to day functions related to review and negotiation of the portfolio.
- Promote and participate in a highly collaborative and high-performance contracts management team culture.
- Work closely with the Associate Director towards the improvement of tools and
- systems to provide critical operational information and make actionable recommendations.
- Participate in the development and maintenance of templates for contracts and
- agreements in the contracts lifecycle management system. Leverage deep
- knowledge of industry funding/support contracts in the clinical trial environment
- and related contracting templates.
- Identify and ensure the flow down of terms from master/prime agreements to work orders and subcontracts.
- Ensure terms and conditions across agreements, including agreements using different funding sources, do not conflict, and mitigate risk and address identified liabilities.
- Administer the drafting, review, negotiation, and execution of all contracts and agreements in the portfolio, including CTAs, amendments, subcontracts, work orders, vendor agreements, license agreements, CDAs, MTAs, and DUAs.
- Administer and perform negotiations in high-stakes contract discussions, ensuring mutually beneficial agreements.
- Ensure timely and accurate processing of contracts to meet organizational objectives.
- Stay abreast of changes in industry [and federal] regulations affecting contracts.
- As needs arise, provide support in the administration, drafting, review and negotiation of all agreements related to federally funded activity.
- Liaise with Contracts Management team members to ensure alignment of terms between industry-related agreements and federal-related agreements on hybrid activities.
Cross-functional Analytical and Change Management:
- Analyze contract management metrics to inform continuous improvement efforts and executive reporting.
- Design and deliver training sessions and user guides to support CLM system onboarding and adoption.
Compliance and Risk Management:
- Administer all contracts in the Manager’s portfolio to ensure compliance with industry prime terms and conditions, federal regulations, organizational policies, and applicable laws.
- Identify and mitigate potential risks in contract terms and conditions.
- Collaborate with the Associate Director and Senior Director to address legal and compliance issues.
Collaboration and Coordination:
- Serve as a back-up liaison to the Associate Director of Contracts Management in connection with the industry-related agreements’ portfolio, reporting directly to the Senior Director of Contracts Management as may be required from time to time.
- Collaborate with internal stakeholders, including finance, legal, and program teams, to align agreements and CLM with organizational goals.
- Serve as back-up liaison to Manager, Federal Grants and Contracts in connection with that agreements portfolio.
Reporting and Analysis:
- Prepare and regularly present reports (weekly, bi-weekly, monthly as required) to the Associate Director of Contracts Management relative to contract status, perceived risks, and opportunities to improve. Collaborate with senior leadership under the direction of the Associate Director of Contracts Management to deliver actionable CLM results.
- Follow trends in contracting practices and CLM, as well aa endeavor to make recommendations for improvements to policies and procedures.
Other Responsibilities:
- All other duties as assigned.
Why Join Us:
This is a unique opportunity to be on the ground floor of a critical role within a mission-driven organization. This position will play a vital part in shaping the contracting function of the Children’s Oncology Group, contributing to lasting change and making a difference in the lives of children and families impacted by cancer.
If you are a strategic, ethical hands-on contracts management leader with a passion for nonprofit work and a commitment to excellence, we encourage you to apply.
FAIR LABOR STANDARDS ACT (FLSA) STATUS
This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.
EEO STATEMENT
The Children’s Oncology Group (COG) is an Equal Employment Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and employees without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
COG believes that diversity and inclusion among our employees is critical to our success, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. Employment at COG is based on merit, competence, and qualifications, and we are committed to providing equal opportunities for training and advancement for all employees. COG is also committed to making our application process accessible to individuals with disabilities and will provide reasonable accommodation upon request. For further information regarding Equal Employment Opportunity, please feel free to access it here.
ADA STATEMENT
The Children’s Oncology Group is committed to providing access and reasonable accommodation in its services, programs, activities and employment for individuals with disabilities. To request disability accommodation in the application process, contact the Recruitment Team at least 72 hours in advance at career@evolvehr.com.
This position falls under a contract with the Federal Government and is subject to the provisions in OMB Circular A-76 which prohibit contractors from performing inherently governmental functions. Specifically, employees placed in agency positions will not perform inherently governmental functions, nor supervise any personnel other than the contractor’s own staff, nor make final decisions or sign documents that commit the U.S. Government.
Requirements
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Minimum Qualifications
- Bachelor’s degree in business administration, law, finance or relevant discipline (e.g., Science) or substitute with 4 additional years of related experience.
- 6 years in human clinical research administration and/or relevant contracting experience, inclusive of 3-5 years of proven experience in industry sponsored and supported clinical trial research with an understanding of contracts and subcontracts.
Other Qualifications:
- Deep experience with industry clinical research agreements, contracts, and actively participate in the development and maintenance of templates for industry agreements.
- Ability to identify and ensure flow down terms from master/prime agreements to workorders and subawards.
- Keen attention to detail, ensuring terms and conditions across, primarily, federal agreement-types no matter the nature of funding mechanisms, are consistent throughout, potential risk is mitigated, and prospective liability is addressed.
- Experience administering the drafting, review and negotiation of industry funded research contracts.
- Strong negotiation, analytical, and problem-solving skills.
- Familiarity with contract law, compliance requirements, and risk management practices.
- Prior experience implementing, administering or supporting a contract lifecycle management system (DocuSign CLM or Sponsored Research System strongly preferred).
- Understanding of contract metadata, clause libraries, workflow design, and automated approval processes.
- Familiarity with the sponsored research and clinical trials contracting process, including regulatory and compliance obligations.
- Experience with business process mapping, cross-functional stakeholder engagement, and change management.
- Prior experience working at or with human research organizations and CROs.
- Data-driven mindset; someone who can track KPIs around contract turnaround times, bottlenecks, and usage rates.
- Able to lead change management and user training.
- Ability to be self-directed as well as a drive towards collaboration, innovation, and pursuit of creative solutions that advance the mission and impact of the organization.
- Comfortable driving change in a fast-paced environment.
- Desire to engage with key stakeholders to better understand the organization’s operations, pursue new opportunities as well as solutions to meet organizational needs.
- Possess a forward-thinking mindset and the ability to think critically about business challenges with an eye towards problem solving and decision making.
- Excellent written and verbal communication skills.
- Ability to exercise a high degree of judgment and diplomacy as well as maintaining the highest integrity and ethics.
Preferred Qualifications:
- JD degree preferred.
- Experience with contract drafting, negotiation and finalization of complex clinical research related agreements.
- Advanced proficiency in Microsoft Office Suite.
- Experience with contracts management lifecycle systems.
- Experience with federal funding related agreement requirements and guidelines.
