At Parexel FSP, you will be working in a team with diverse experience and knowledge. We are looking for people like you who take the initiative to make things better, and bright minds who want to grow personally and professionally. We recognize and value the importance of all people, the way we work, our drive for innovation and, most importantly, our patients.

We are looking for a Senior Analyst Clinical Site Contracts, German&Polish speaker to work 100% remotely in EU. The job is dedicated to one sponsor.

This role will be part of the Site Contracts & Budgets team, working to execute the clinical site contracts and budgets process for Sponsor clinical development programs, from contract initiation to completion, maintenance, and subsequent amendments.

The Senior Analyst must have a good understanding of functions related to the conduct of global clinical studies. Under the direction of the Director, Clinical Outsourcing & Innovation, the Senior Analyst is responsible for executing the end-to-end site contracts process for assigned agreements and supporting the wider site contracts & budgets team to maintain overall standards, financial terms, and compliance for all site contracts.

Working as a Senior Analyst, Site Contracts & Budgets at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts.

• As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols.

• Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines.

• Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts.

• Oversee CRO and Functional Service Provider activities.

• Collaborate and coordinate with cross-functional teams; R&D, Legal, Compliance, Procurement and Finance in executing contracts.

• Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting.

• Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes.

• Provide accurate progress updates to Clinical Operations teams on all outstanding contracts and budgets

• Complete required quality checks of appropriate documents and records for completeness and accuracy and ensure adherence to department guidelines/templates; collate quality issues for reporting to team leads.

• Assist management with process improvement projects.

• Coordinate and arrange meetings, prepare agendas, and meeting planning.

• Submit purchase requisitions, where needed, through SAP systems.

• Support the development and maintenance of guidelines, training programs, policies and procedures related to clinical trial contracts and budget.

• Support the Director and team in the management of other day-to-day activities related to clinical contracts and budgets as requested.

We expect from you

• 3 – 5 years’ experience in the pharmaceutical or biotechnology industry in clinical site contracts and/or outsourcing management.

• Fluent German, Polish or another Eastern European speaker.

• Fluent English.

• Proficient with Excel and PowerPoint.

• Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization.

• Willingness to learn international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues.

• Strong interest in learning more about contracts and budgeting in support of Sponsor clinical trials.

• Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety.

• Ability to prioritize and manage multiple tasks simultaneously.

Become part of a global community where you can turn your career into a lifetime achievement.

Apply directly or contact us via email at marta.kuniewicz@parexel.com