Contract Specialist - FSP
• Work Schedule
• Standard (Mon-Fri)
• Environmental Conditions
• Office
• Job Description
• Join Us as a Site Contract Specialist – Make an Impact at the Forefront of Innovation
• We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to prepare and negotiate contracts, as well as finalize the contract process. As a Site Contract Specialist, you'll liaise and establish effective relationships with sites and internal functional teams. You will ensure quality, objectivity, and risk analysis in the efficient delivery of contracts.
• What You’ll Do:
• Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
• Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
• Negotiate directly with assigned sites on all site related contracting items including clinical trial agreements, budgets, payment terms, ancillary agreements and amendments.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and deliver processes.
• Ensure standards are applied to the SB&C processes across projects.
• Leverage leading industry tools and data sources to provide budget and contract feedback aligned with parameters and fair market value guidance.
• Promptly recognize and improve potential delays and escalate to appropriate team members.
• Track all actions and negotiations to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the site activation sub-team in partnership with the internal Study Startup team.
• Education and Experience Requirements:
• 2 or more years of experience in clinical research site contracting and budgeting within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and schedule of assessments
• Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
• Understanding of Clinical Trial Agreements, budgeting and fair market value principals
• Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
• .
• Knowledge, Skills and Abilities:
• Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
• Demonstrated ability to apply basic principles of investigator grant negotiation
• General understanding of business and financial principles that related to service agreements
• Effective communication skills (verbal & written) in English and local language
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
• Demonstrated ability in attention to detail
• Excellent analytical and decision based thinking skills
• Understanding of the pharmaceutical product development process and involvement of CROs
• Able to work independently or in a team environment
• Good organizational and time management skills
• Working knowledge of PPD SOP & WPDs
• Able to organize competing priorities logically and review outstanding contractual risk and issues
• Able to effectively use automated systems and computerized applications
• Ability to demonstrate a customer focused style of communication, problem solving and collaboration
• Working Conditions and Environment:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand informat
• Standard (Mon-Fri)
• Environmental Conditions
• Office
• Job Description
• Join Us as a Site Contract Specialist – Make an Impact at the Forefront of Innovation
• We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to prepare and negotiate contracts, as well as finalize the contract process. As a Site Contract Specialist, you'll liaise and establish effective relationships with sites and internal functional teams. You will ensure quality, objectivity, and risk analysis in the efficient delivery of contracts.
• What You’ll Do:
• Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
• Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
• Negotiate directly with assigned sites on all site related contracting items including clinical trial agreements, budgets, payment terms, ancillary agreements and amendments.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and deliver processes.
• Ensure standards are applied to the SB&C processes across projects.
• Leverage leading industry tools and data sources to provide budget and contract feedback aligned with parameters and fair market value guidance.
• Promptly recognize and improve potential delays and escalate to appropriate team members.
• Track all actions and negotiations to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the site activation sub-team in partnership with the internal Study Startup team.
• Education and Experience Requirements:
• 2 or more years of experience in clinical research site contracting and budgeting within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and schedule of assessments
• Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
• Understanding of Clinical Trial Agreements, budgeting and fair market value principals
• Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
• .
• Knowledge, Skills and Abilities:
• Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
• Demonstrated ability to apply basic principles of investigator grant negotiation
• General understanding of business and financial principles that related to service agreements
• Effective communication skills (verbal & written) in English and local language
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
• Demonstrated ability in attention to detail
• Excellent analytical and decision based thinking skills
• Understanding of the pharmaceutical product development process and involvement of CROs
• Able to work independently or in a team environment
• Good organizational and time management skills
• Working knowledge of PPD SOP & WPDs
• Able to organize competing priorities logically and review outstanding contractual risk and issues
• Able to effectively use automated systems and computerized applications
• Ability to demonstrate a customer focused style of communication, problem solving and collaboration
• Working Conditions and Environment:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand informat