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Manager, Clinical Contracts (FSP)

Employer
Parexel
Location
Belgium
Salary
Competitive
Start date
18 Jun 2021
Closing date
18 Jul 2021

View more

Discipline
Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

About ExecuPharm/PAREXEL FSP

A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.



Forresults-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
For our European operations we are currently looking for a Clinical Contracts Manager to be fully home-based in one of the European countries.

The Manager, Clinical Contracts is responsible for leading the clinical study contracts team, supporting Seattle Genetics sponsored clinical trials by providing management and oversight of the clinical study contracts process, including the flow of clinical trial agreement lifecycles, negotiating clinical site budgets, conducting business operations as detailed below, and for ensuring that study deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position will work closely with stakeholders such as clinical study teams, clinical project managers, the Legal department, and clinical study site personnel.

Principal Responsibilities
  • Lead the clinical contract, Master Clinical Trial Agreements (MCTA), Non-Disclosure Agreements (NDA), and vendor contract processes
  • Manage the study site budget process from initial template stage to fully negotiated site contracts and amendments.
  • Analyze site contract trends and develop metrics. Benchmark against industry standards. Establish target goals.
  • Work with stakeholders to identify, evaluate, and implement opportunities to improve processes
  • Conduct contract quality control and remediate as needed
  • Ensure consistency in site payment schedules and terms
  • Serve as clinical contract liaison with the Legal group
  • Serve as clinical contract liaison with Contract Research Organizations (CROs), Site Management Organizations (SMOs) and other partners
  • Work collaboratively with the clinical study teams to ensure Clinical Contract deliverables are identified, communicated appropriately and met
  • Manage the contract and/or budget escalation process
  • Maintain the clinical finance database with site and vendor contract budget data
  • Support maintenance of the Legal contract database

  • People Management
  • Set goals and provide oversight, guidance, mentoring, feedback and performance reviews
  • Manage team workload efficiently across studies to ensure deliverables are met
  • Perform hiring and training activities as needed
  • Provide status updates to management and stakeholders
  • Develop and maintain process documents and tools
  • Adhere to department standards and guidelines
  • Ensure compliance with regulatory requirements
  • Special projects as required
  • Qualifications

    Bachelor's degree in Life Science, Business or equivalent. MBA preferred
    • Minimum four (4) years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialist
    • Experience negotiating contract payment terms and budgets
    • Intermediate Excel and database management skills
    • Knowledge of GCP/ICH requirements
    • Excellent analytical and problem solving skills
    • Requires effective organizational and communication skills
    • Work both independently and ability to successfully work in a "virtual" team environment
    • Has a track record of exceeding goals successfully
    • Partners with others to get work done
    • Follows through on commitments
    • Shows personal commitment and takes action to continuously improve
    • Deals constructively with problems that do not have clear solutions or outcomes
    • Maintains a positive attitude despite adversity
    • Acquires data from multiple and diverse sources when solving problemsWhy Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

    Company

    Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    GB

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