Job Title: Sr Associate Clinical Contracts & Budgets Duration: 1 Year Location: Remote or preference given to local candidates (Thousand Oaks, CA)
Description: ** Please include Word/Excel testing scores on top of resumes when submitting**
Purpose / Accountabilities Provide clinical site contracting services to clinical study teams to support study start up and conduct activities
Responsibilities Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving). Support site-related questions regarding invoice preparation with respect to submission of invoices in company's Payment System (eGPS) Support resolution of contract and budget issues Support contracting with local GSO vendors Maintain contract tracking in appropriate systems Manage Confidential Disclosure Agreement proces Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness Ensure payments are made in accordance with contracts Maintain payment data tracking in appropriate systems Responsible for providing information for entry into systems
Key Activities Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final budget for inclusion in the contract Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems Support Clinical Pricing & Payments Group in setting up sites for eGPS , ClinCard or legacy systems. Track contract progression using appropriate systems Amend and terminate contracts as necessary throughout lifecycle of study Store and archive contracts and budgets in appropriate systems Maintain payment records and provide assistance with audit review records Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2. Responsible for the contracting process and/or point-of-contact for vendor for locally outsourced studies Responsible for the Clinical Trials Insurance process Participate in appropriate site/legal meetings as required to resolve contract issues Participate in appropriate site/finance meetings as required to resolve payment issues Maintain party information and contract activation in Contract Generation System Approve or reject clinical invoices Process and track Confidential Disclosure Agreements as appropriate Manage contracting process with Clinical Trial Related Consulting Agreements Manage all study-related Site payments not managed by Clinical Pricing & Payments Group
Must Haves: - Recent (within last 3 years) contract and budget negotiation experience in a clinical trial setting. - Directly involved with the negotiation of terms for various contract types (CTA, CDA, Master Agreements, etc) and site budgets. We want to make sure they are not just a “middle man” passing the contract from clinical trial site/sponsor to legal. - The following competencies: Attention to detail Negotiation skills Organizational Skills Relationship management Time management & prioritization Flexibility Written and oral communication skills Good working knowledge of common software packages (e.g. Office 365 esp. Excel, Word, SharePoint, Microsoft Teams, SAP) Data analysis and presentation skills Problem solver Team work
Red Flags - No contract negotiation experience - No (or very little) experience with clinical trial contracts - Background in supply chain management/payments only - Contract experience heavily leans on administrative side (execution, filing, tracking – not negotiation) - Last clinical contracting experience -3 years ago - Lack of stable work history (1-2 month assignments with significant gaps)
Basic Qualifications Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience
Top 3 Must Have Skill Sets: - Recent (within last 3 years) contract and budget negotiation experience in a clinical trial setting. - Active/involved negotiation with various contract types (CTA, CDA, Master Agreements, etc). We want to make sure they are not just a “middle man” passing the contract from clinical trial site/sponsor to legal. - Proficient with Microsoft Office programs, with focus on Excel
Day to Day Responsibilities: Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving). Support site-related questions regarding invoice preparation with respect to submission of invoices in company's Payment System (eGPS) Support resolution of contract and budget issues Support contracting with local GSO vendors Maintain contract tracking in appropriate systems Manage Confidential Disclosure Agreement process Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness Ensure payments are made in accordance with contracts Maintain payment data tracking in appropriate systems Responsible for providing information for entry into systems Employee Value Proposition: ... Possible Extension: Yes Red Flags: - No contract negotiation experience - No (or very little) experience with clinical trial contracts - Background in supply chain management/payments only - Contract experience heavily leans on administrative side (execution, filing, tracking – not negotiation) - Last clinical contracting experience 3 years ago - Lack of stable work history (1-2 month assignments with significant gaps Interview Process: Panel interview with hiring manager and others
Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.00/hr.
