Senior Associate Clinical Contracts & Budgets

Orion Group Life Sciences are looking for a Senior Associate Clinical Contracts & Budgets on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension. This is a hybrid position, where you have to be 2 days per week in the office. During initial onboarding this will be more. This is a part-time position, 32 hours.

Purpose of the position

• 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 the Payment System of our client.
• Support resolution of contract issues.
• Support contracting with local vendors (translation vendors, printing 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 using appropriate guidelines and collect necessary signatures for contract execution.
• Negotiate site budgets using appropriate guidelines.
• Escalate contract and budget issues to the appropriate stakeholders.
• Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment 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.
• Involvement in obtaining legal approval for changes to legal parts in consent documents.
• Responsible and/or point-of-contact at vendor level for the contracting process 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.
• Approve or reject clinical invoices.
• Process and track confidential disclosure agreements as appropriate.
• Manage contracting process with clinical trial related consulting agreements.

Required Qualifications and skills

• Master’s degree OR Bachelor’s degree.
• Relevant work experience in life sciences or medically related field.
• Experience in interactions with outside vendors.
• Relevant work experience in Legal, Negotiation and/or Finance.
• Working effectively in a team/matrix global environment.
• Flexibility.
• Ability to understand technical, scientific and medical information.
• Good organizational, planning and problem-solving skills.
• Dealing with time demands, incomplete information or unexpected events.
• Attention to detail.
• Written and oral communication in English and Dutch.
• Relationship building.
• Time management & prioritization.
• Working knowledge of ICH Good Clinical Practice (GCP), Understanding of drug development process and concepts of clinical research.
• Good working knowledge of common software packages (e.g. Office 365 esp. Excel, SAP).
• Negotiation skills.

If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, tim.browaeys@orion-jobs.com or contact Tim on 0044 7593448607

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