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 Romania.
Essential Function :
The main responsibility of the Site Contract Leader is to manage the entire Clinical Site Agreement (CSA) process for a number of projects.
This includes the development of the study specific CSA strategy with the Sponsor, the preparation of corresponding country specific CSA templates and country specific budgets and the negotiation of such CSAs and budgets with individual sites located in his / her region / country.
Further, the responsibilities include managing CSA activities and liaising with Project Leaders, Clinical Operations Leaders 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.
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 fallback 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.
Participate in client, investigator and team meetings, as required.
Prioritize effectively and respond to urgent requests within team or sponsor lead.
Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and Parexal SOPs and study specific procedures.
Relevant work experience in Contracting or Clinical Operations or in Legal (Paralegal).
Fluency in written and spoken English and German is required; Polish and any other languages fluency would be an asset.
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.
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.
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.