Pricing and Contract Strategy Manager
Title:
Clinical Contract ManagerLocation:
Wilmington DEDuration:
12 Months Pay Range:
$60 - $62/hourThis is a tentative pay rate and depends on your total experience and skillsEmployee benefits include but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Brief
Job Description:
Major responsibilitieso Develop and negotiate clinical site budgets based on Fair Market ValueLeverage historical data, and negotiation techniques, and address SoC with sites to realize cost savings.
o Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up, and financial obligations.
o Be responsible for producing clinical site budget appropriate Payment Schedules based on the Protocol and CLIENT policy and guidelines to provide to the Clinical Delivery Team.
o Formulate and identify the proper agreement template to initiate negotiations.
o Act as point of contact and interface with Legal if necessary to ensure the integrity of contracts.
o Drive site start-up time by striving to execute CSA within KPI.
o For each agreement maintain the status of agreement, budgets, issues, and communications with both internal and external sources.
o Attend and engage in scheduled project team meetings.
o Ensure final contract documents are consistent with agreements reached at negotiations.
o Ensure all agreements are completed or captured in contracting systemo Support internal and external audits and litigation activitieso Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated documents.
o Ability to process agreement requests and identify correct legal entity and template to be used.
o Approve Clinical Study Agreements with final signature, according to Delegation of Authority.
o Negotiate a variety of common contractual issues related to standard template agreements.
o Process amendments to contracts, as necessary, and manage that modification.
o Work with study teams to determine priorities for meeting timelines and SIV dates.
o Serve as a liaison between the legal and clinical trial teams.
o Negotiate master templates with preferred or notable Institutions.
o As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
o As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers.
o As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process and budget development.
o Communicate confidently and competently to liaise with others through excellent communication and negotiation skills.
o Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management).
o Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes.
o Demonstrate ability to follow and work within processes.
o Ensure compliance with client's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Additional Responsibilities May Includeo Ensure timely customization and completion of the CSA for designated studies.
o Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and CLIENT Procedural documents.
o Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File.
o Contribute to process improvements, knowledge transfer, and best practice sharing.
Minimum Requirements and Preferred Backgroundo Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
o Post-graduate training in contracts administration or work experience as a paralegal in the pharmaceutical or healthcare industry.
o Strong interpersonal, negotiation, communication, and time management skills.
o Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.
o Five years' experience in the pharmaceutical or healthcare industry, or seven to ten years of experience as a paralegal or contractor administrator in the pharmaceutical industry.
o Strong oral, written, and organizational skills.
o Fluent knowledge of spoken and written English.
o Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
o Good knowledge of relevant local regulations.
o Good medical knowledge in relevant CLIENT Therapeutic Areas.
o Basic understanding of the drug development process.
o Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
o Ability to adapt to changeAbility to travel nationally as required.
Competencies and Skillso Maintain the ability to deliver quality according to the requested standards.
o Demonstrate ability to work in an environment of remote collaborators.
o Manage change with a positive approach for self, team, and the businessSees change as an opportunity to improve performance and add value to the business.
o Exhibit the ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with a reduced budget and in less time.
o Demonstrate excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.
o Possess good analytical and problem-solving skills.
o Demonstrate ability to prioritize and manage multiple tasks with conflicting deadlines.
o Possess good cultural awareness.
o 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.
o Maintain team team-oriented and flexible approach; possess the ability to respond quickly to shifting demands and opportunities.
o Exhibit customer focus in collaboration with sites and external stakeholders.
#tel2 Recommended Skills Adaptability Administration Analytical Biology Clinical Works Coaching And Mentoring Apply to this job.
Think you're the perfect candidate? Apply Now Estimated Salary: $20 to $28 per hour based on qualifications.
Clinical Contract ManagerLocation:
Wilmington DEDuration:
12 Months Pay Range:
$60 - $62/hourThis is a tentative pay rate and depends on your total experience and skillsEmployee benefits include but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Brief
Job Description:
Major responsibilitieso Develop and negotiate clinical site budgets based on Fair Market ValueLeverage historical data, and negotiation techniques, and address SoC with sites to realize cost savings.
o Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up, and financial obligations.
o Be responsible for producing clinical site budget appropriate Payment Schedules based on the Protocol and CLIENT policy and guidelines to provide to the Clinical Delivery Team.
o Formulate and identify the proper agreement template to initiate negotiations.
o Act as point of contact and interface with Legal if necessary to ensure the integrity of contracts.
o Drive site start-up time by striving to execute CSA within KPI.
o For each agreement maintain the status of agreement, budgets, issues, and communications with both internal and external sources.
o Attend and engage in scheduled project team meetings.
o Ensure final contract documents are consistent with agreements reached at negotiations.
o Ensure all agreements are completed or captured in contracting systemo Support internal and external audits and litigation activitieso Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated documents.
o Ability to process agreement requests and identify correct legal entity and template to be used.
o Approve Clinical Study Agreements with final signature, according to Delegation of Authority.
o Negotiate a variety of common contractual issues related to standard template agreements.
o Process amendments to contracts, as necessary, and manage that modification.
o Work with study teams to determine priorities for meeting timelines and SIV dates.
o Serve as a liaison between the legal and clinical trial teams.
o Negotiate master templates with preferred or notable Institutions.
o As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
o As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers.
o As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process and budget development.
o Communicate confidently and competently to liaise with others through excellent communication and negotiation skills.
o Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management).
o Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes.
o Demonstrate ability to follow and work within processes.
o Ensure compliance with client's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Additional Responsibilities May Includeo Ensure timely customization and completion of the CSA for designated studies.
o Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and CLIENT Procedural documents.
o Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File.
o Contribute to process improvements, knowledge transfer, and best practice sharing.
Minimum Requirements and Preferred Backgroundo Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
o Post-graduate training in contracts administration or work experience as a paralegal in the pharmaceutical or healthcare industry.
o Strong interpersonal, negotiation, communication, and time management skills.
o Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.
o Five years' experience in the pharmaceutical or healthcare industry, or seven to ten years of experience as a paralegal or contractor administrator in the pharmaceutical industry.
o Strong oral, written, and organizational skills.
o Fluent knowledge of spoken and written English.
o Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
o Good knowledge of relevant local regulations.
o Good medical knowledge in relevant CLIENT Therapeutic Areas.
o Basic understanding of the drug development process.
o Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
o Ability to adapt to changeAbility to travel nationally as required.
Competencies and Skillso Maintain the ability to deliver quality according to the requested standards.
o Demonstrate ability to work in an environment of remote collaborators.
o Manage change with a positive approach for self, team, and the businessSees change as an opportunity to improve performance and add value to the business.
o Exhibit the ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with a reduced budget and in less time.
o Demonstrate excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.
o Possess good analytical and problem-solving skills.
o Demonstrate ability to prioritize and manage multiple tasks with conflicting deadlines.
o Possess good cultural awareness.
o 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.
o Maintain team team-oriented and flexible approach; possess the ability to respond quickly to shifting demands and opportunities.
o Exhibit customer focus in collaboration with sites and external stakeholders.
#tel2 Recommended Skills Adaptability Administration Analytical Biology Clinical Works Coaching And Mentoring Apply to this job.
Think you're the perfect candidate? Apply Now Estimated Salary: $20 to $28 per hour based on qualifications.
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