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Form of workCDMA Clinical Contract Manager
Pay Rate: $31.47/hr - $46.39/hr
Location: Onsite - Pleasanton CA 94588
Duration: 1 year
Position Summary:
The Clinical Contracts Specialist Sr (position title may be Clinical Contracts Manager) works closely with project, people, and functional leaders across Clinical Operations & Biometrics, Procurement, Legal, Finance, and Suppliers to ensure appropriate contracts are in place for COBM projects and payments associated to contracts are issued to vendors.
DISTINGUISHING CHARACTERISTICS:
This is a job requiring a combination of advanced skills and experience in drafting, negotiating, and finalizing contracts for COBM related services.
Responsibilities
" Drafts, reviews and negotiates clinical trial agreements (Master Service Agreements, Work Orders, and Clinical Trial Agreements) and site budgets with US and ex-US institutions.
" Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate and finalize budget amendments.
" Provide continuing support on executed agreements (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise).
" Work closely and communicate with members of the Lifecycle Finance teams and other internal stakeholders; provide timely updates on contract and site budget status , identifying and escalating any potential critical path items as appropriate.
" Track, maintain and update assigned contract information within the COBM Clinical Trial Management System (CTMS) and other tracking tools, to ensure completeness and accuracy, as applicable.
" Works with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.
" Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.
" Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO s, and report spend as necessary.
" Other tasks may be assigned from time to time to support overall COBM function.
" Other duties as assigned by management.
Qualifications
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Education:
(Required) Bachelor's Degree in Business / Finance or industry related field
(Preferred) Master s Degree in Business / Finance or industry related field
Experience:
Equivalencies are not acceptable
Required:
5 Years of contract drafting, negotiation, and finalizing experience within diagnostics and/or pharmaceutical industry.
5 years of specific RFI, RFP, Contracting and/or budget management experience
Preferred:
4 years of clinical trial experience
Knowledge, Skills and Abilities:
Clinical Trial services
Contracting: Master Services Agreement content nad contract negotiations
Travel requirements based on business needs.
Benefits: (employee contribution)
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Rate: $31.47/hr - $46.39/hr
Location: Onsite - Pleasanton CA 94588
Duration: 1 year
Position Summary:
The Clinical Contracts Specialist Sr (position title may be Clinical Contracts Manager) works closely with project, people, and functional leaders across Clinical Operations & Biometrics, Procurement, Legal, Finance, and Suppliers to ensure appropriate contracts are in place for COBM projects and payments associated to contracts are issued to vendors.
DISTINGUISHING CHARACTERISTICS:
This is a job requiring a combination of advanced skills and experience in drafting, negotiating, and finalizing contracts for COBM related services.
Responsibilities
" Drafts, reviews and negotiates clinical trial agreements (Master Service Agreements, Work Orders, and Clinical Trial Agreements) and site budgets with US and ex-US institutions.
" Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate and finalize budget amendments.
" Provide continuing support on executed agreements (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise).
" Work closely and communicate with members of the Lifecycle Finance teams and other internal stakeholders; provide timely updates on contract and site budget status , identifying and escalating any potential critical path items as appropriate.
" Track, maintain and update assigned contract information within the COBM Clinical Trial Management System (CTMS) and other tracking tools, to ensure completeness and accuracy, as applicable.
" Works with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.
" Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.
" Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO s, and report spend as necessary.
" Other tasks may be assigned from time to time to support overall COBM function.
" Other duties as assigned by management.
Qualifications
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Education:
(Required) Bachelor's Degree in Business / Finance or industry related field
(Preferred) Master s Degree in Business / Finance or industry related field
Experience:
Equivalencies are not acceptable
Required:
5 Years of contract drafting, negotiation, and finalizing experience within diagnostics and/or pharmaceutical industry.
5 years of specific RFI, RFP, Contracting and/or budget management experience
Preferred:
4 years of clinical trial experience
Knowledge, Skills and Abilities:
Clinical Trial services
Contracting: Master Services Agreement content nad contract negotiations
Travel requirements based on business needs.
Benefits: (employee contribution)
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
