REMOTE Clinical Contract Manager

Kelly is hiring for a REMOTE- Clinical Contract Manager position with one of our clients in Wilmington, DE.

• Full time- W2

• 12 months contract (May be extended or converted)

• $55/hr

Job Description:

A position providing leadership during the clinical agreement and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets. This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication, and stakeholder management. This role requires a high level of interactive communication to set clear direction for the study teams and external Institutions.

• Develop and negotiate clinical site budgets based on Fair Market Value. Leverage historical data, negotiation techniques, and address SoC with sites to realize cost savings.

• Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations.

• Be responsible for producing clinical site budget appropriate Payment Schedules based on the Protocol and policy and guidelines to provide to Clinical Delivery Team.

• Formulate and identify the proper agreement template to initiate negotiations.

• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.

• Drive site start-up time by striving to execute CSA within KPI.

• For each agreement maintain the status of agreement, budgets, issues, and communications with both internal and external sources.

• Attend and engage in scheduled project team meetings.

• Ensure final contract documents are consistent with agreements reached at negotiations.

• Ensure all agreements are completed or captured in contracting system system

• Support internal and external audits and litigation activities.

• Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated documents.

• Ability to process agreement requests and identify correct legal entity and template to be used.

• Approve Clinical Study Agreements with final signature, according to Delegation of Authority.

• Negotiate a variety of common contractual issues related to standard template agreements.

• Process amendments to contracts, as necessary, and manage that modification.

• Work with study teams to determine priorities for meeting timelines and SIV dates.

• Serve as a liaison between the legal and clinical trial teams.

• Negotiate master templates with preferred or notable Institutions.

• As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.

• As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers.

• As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process and budget development.

• Communicate confidently and competently to liaise with others through excellent communication and negotiation skills.

• Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management).

• Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes.

• Demonstrate ability to follow and work within processes.

• Ensure compliance with Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Additional Responsibilities May Include:

• Ensure timely customization and completion of the CSA for designated studies.

• Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and Procedural documents.

• Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File.

• Contribute to process improvements, knowledge transfer and best practice sharing.

Qualifications and Education Requirements:

• Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.

• Strong interpersonal, negotiation, communication and time management skills.

• Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.

• Five years' experience in pharmaceutical or health care industry, or seven to ten years of experience as paralegal or contractor administrator in pharmaceutical industry.

• Strong oral, written, and organizational skills.

• Fluent knowledge of spoken and written English.

• Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Good medical knowledge in relevant Therapeutic Areas.

• Basic understanding of the drug development process.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

• Ability to adapt to change

• Ability to travel nationally as required.

Preferred Skills:

• Maintain ability to deliver quality according to the requested standards.

• Demonstrate ability to work in an environment of remote collaborators.

• Manage change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

• Exhibit ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Demonstrate excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.

• Possess good analytical and problem solving skills.

• Demonstrate ability to prioritize and manage multiple tasks with conflicting deadlines.

• Possess good cultural awareness.

• Prove ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

• Maintain team oriented and flexible approach; possess ability to respond quickly to shifting demands and opportunities.

• Exhibit customer focus in collaboration with sites and external stakeholders

Important information: This position is recruited for by a remote Kelly office , not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online to be considered for the position.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. That's why we're proud to offer a complete array of voluntary benefits to members of the Kelly talent community.

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (~~~) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.