Senior Associate Clinical Contracts & Budgets (33584)

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

• Facilitate and support the operational implementation of single country Investigator Sponsored Studies (ISS) and support country specific operational implementation of multi-country ISS from planning to close-out.
• Facilitate country-specific operational implementation of Expanded Access (EA) requests.
• Provide clinical site contracting services to clinical study teams to support study start up and conduct activities.

Responsibilities

• Investigator Sponsored Studies (ISS):
  • Serve as operational point of contact to stakeholders and across functions for single country ISS
  • Support ISS Manager in facilitating operational ISS processes in accordance with global SOPs and other supporting documentation for multi-country ISS with contract in respective country
  • Partner with stakeholders to ensure timely and appropriate support of single country ISS deliverables.
  • Data entry and tracking in source systems.
  • Maintain tracking of single country ISS proposals and protocols and facilitate review and approval process.
  • Support set-up activities and provide sponsor support according to the SOPs for single country ISS's.
  • Liaise with Sponsor, Medical POC and internal budget holder to ensure good financial governance of single country ISS.
  • Serve as operational point of contact to stakeholders and across functions for country-specific EA requests (with regional ISS Manager /team guidance and oversight).
  • Assist the ISS Manager/Senior Manager/Director in support of ISS activities including process improvement and issue resolution.
• Clinical Contracts & Budgets (SCBA):
  • 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 our client's Payment System.
  • Support resolution of contract issues.
  • Support contracting with local vendors (translation vendors, printing vendors, …).
  • Maintain contract tracking in appropriate systems.
  • 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

• Investigator Sponsored Studies (ISS):
  • Track receipt of single country ISS concepts/proposals from Investigator Sponsor.
  • Facilitate sponsor communication for single country ISS in collaboration with Medical POC for quality and completeness of end-to end ISS process (e.g. provision of scientific comments on protocol and actions arising from due diligence).
  • Complete sponsor qualification process for single country ISS's and support process for multi-country ISS with contract.
  • Facilitate execution of Confidential Disclosure Agreement where required.
  • Facilitate process for cross functional review of proposals, protocols and amendments.
  • Support meetings internally and with Sponsor as appropriate (drafting agendas, minutes, etc).
  • Provide protocol submission package and open study packets to sponsor.
  • Partner with Supply Chain representative regarding set-up and continuity of supply for single country ISS, including temperature excursions and product complaint processing as required.
  • Partner with Global Pricing Department regarding conduct of Fair Market Value assessment for single country ISS.
  • Support sponsor notification of any actions or information required from Due Diligence.
  • Initiate and support the contract execution process in collaboration with Senior Associate Clinical Contracts and Budgets and Legal Counsel.
  • Support the collection and completion of ISS Regulatory Assessment (ISSRA) and ISS Initiation Package (ISSIP) documents.
  • Enter data (including milestone tracking and enrolment status) into and maintain source systems.
  • Track essential documentation and archive in Central Document Repository
    Procure updates from the sponsor regarding enrolment, milestone payments, etc, per contract, obtain confirmation on milestone payments per contract.
  • Facilitate provision of safety updates to Sponsor and reporting and reconciliation of SAEs.
  • Liaise with external CRO vendors appointed by the sponsor, as necessary.
  • Support our client review of ISS publications for single country ISS.
  • Communicate and/or support communication of study status (including planned vs. actual timelines) to key stakeholders and management as requested.
  • Procure product reconciliation and destruction confirmation from sponsor.
  • Review single country ISS metrics and assist with measurement of compliance to process requirements.
  • Facilitate process, as operational point of contact, for local EA requests.
  • Support regional ISS representatives regarding local issues.
  • Identify, facilitate and support resolution of ISS and EA cross-functional issues.
• Clinical Contracts & Budgets (SCBA):
  • 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

• Experience with Investigator Sponsored Studies (ISS).
• Experience with Clinical Contracts & Budgets (SCBA).
• Working knowledge of ICH Good Clinical Practice (GCP) - Must Have.
• Working effectively in a team/matrix global environment.
• Ability to understand technical, scientific and medical information.
• Understanding of drug development process and concepts of clinical research.
• 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.
• Policy, process and procedural conformance.
• Time management & prioritization.
• Team work.
• 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@orioneng.com or contact Tim on 0044 7593448607

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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.