Senior Associate Clinical Contracts & Budgets

Senior Associate Clinical Contracts & Budgets

Location : Remote

Duration : months with possible extension

Description :

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 Client 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

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 .

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 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.

Active / involved negotiation with various contract types (CTA, CDA, Master Agreements, etc).

Proficient with Microsoft Office programs, with focus on Excel

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 ( Office 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 - years ago

Lack of stable work history (- month assignments with significant gaps)

Basic Qualifications

Master degree OR Bachelor degree and years of experience OR Associate degree and years of experience