Senior Site Contract Leader

22 Apr 2021
22 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for a Senior Site Contract Leader to be homebased in Poland.

The main responsibility of the Senior Site Contract Leader is managing the entire Clinical Site Agreement (CSA) process principally for a number of complex projects, including the development of the study specific CSA strategy with the Sponsor, preparation of the corresponding country specific CSA templates and country specific budgets and also negotiation of such CSAs and budgets with the individual sites located in his/her region/country. The Senior Site Contract Leader can also work in a coordination role at a global level for a clinical study or a program of clinical studies. Further, the responsibilities include managing CSA activities and liaising with PL, COL and the Sponsor to ensure that the CSA start-up deliverables are met.

Key Accountabilities
  • Act as functional Leader on projects and develop study specific CSA strategy.
  • Support site confidential disclosure agreements (Site CDA) negotiations, as required.
  • Subject to determined study characteristics, act as a SCL coordinator at a global level.
  • Agree and negotiate study specific generic and/or country CSA templates and, subject to the input provided by other internal areas, negotiate the country budgets with the Sponsor.
  • Gather relevant study information from PL/COL.
  • Discuss and finalize specific country CSA templates with input from Sponsor, PL and/or COL, if appropriate.
  • Upon Sponsor approval of the country specific template, store the final approved and complete country CSA template and country budget in PMED, along with the corresponding CSA approval form.
  • Arrange translations of CSA templates to local language.
  • Prepare and negotiate with sites the respective CSA in accordance with the CSA strategy agreed with the Sponsor, CSA turnaround timelines, CTMS tracking requirements and budget negotiation parameters. Work within the defined "fallback" / approval parameters to manage / resolve significant CSA changes requested by the site
  • Escalate changes that fall outside the documented "fall-back" parameters, if available, to the Sponsor, SCL line manager, or any other internal point of escalation, as appropriate and ensure that sufficient background information is supplied.
  • Proactively keep PL/COL informed about CSA progress and any issues/challenges during the CSA negotiation.
  • Maintain CSA negotiation status accurately tracked in CTMS
  • Collect CSA signatures
  • File fully executed CSA
  • Maintain comprehensive language tracker
  • Early recognition of areas of potential problems and formulate contingency plans
  • Participate in client, investigator and team meetings, as required.
  • Maintain and assure quality of work generated
  • Prioritize effectively and respond to urgent requests within team or sponsor lead
  • Provide mentoring and coaching to SCL or Associate SCL staff
  • Work as a Subject Matter Expert (SME) for a specific area, matter and/or client and support the SCL team in such capacity.
  • Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and PAREXEL SOPs and study specific procedures
  • Qualifications

    Minimum Work Experience
  • Experienced SCL or a senior person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal) or in a comparable function in another CRO or pharmaceutical company
  • Skills
  • Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability
  • Excellent interpersonal, verbal and written communication skills
  • Ability to motivate both individuals and a team.
  • Ability to successfully work in a "virtual" team environment
  • Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
  • Effective time management in order to meet daily metrics or team objectives
  • Shows commitment to and performs consistently high quality work
  • Ability to identify and address issues proactively in a timely manner
  • Ability to take initiative, work independently and delegate
  • Accountability for all assigned tasks
  • Excellent computer and internet skills including knowledge of MS- Office products such as Excel, Word
  • Education
  • Degree in business, legal or life science or other relevant work experience in Contracting, Clinical Operations or in Legal (Paralegal).
  • Language Skills
  • Fluent in written and spoken English in addition to local language.
  • Why 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.

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