Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 French speaking Site Contract Associate based in the EMEA region.

The main responsibility of the Site Contract Lead is the negotiation of study specific generic and country Clinical Site Agreement (CSA) templates with the Sponsor and support the PL in the negotiation of country budgets with the Sponsor as well as providing the local CTS/CRA with required CSA country templates.

Further, the responsibilities include managing CSA activities and liaising with PL, GRO Lead and the Sponsor to ensure that the CSA start-up deliverables are met. The Site Contract Associate is responsible for the coordination of the local CTS /CRA working on CSAs on a project level.

Key Accountabilities:

Act as functional Specialist on projects and develop study specific CSA strategy
Agree and negotiate study specific generic and country CSA templates with the Sponsor and
support the PL in the negotiation of country budgets with the Sponsor
Gather relevant study information from PL
Discuss and finalize specific country CSA templates with input from Sponsor, PL and GRO Lead if appropriate
Upon sponsor approval of the country specific template, store the final approved and complete country template and country budget PMED
Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements and budget information/updates with the assigned CTS/CRAs
Provide agreed study and country CSA templates to local CTS/CRA for country specific adaptation
Coordinate interaction between GRO Lead, PL and Sponsor including overall timeline management for CSAs
Coordinate overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/PL
Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is up-to-date
Maintain comprehensive language tracker
Early recognition of areas of potential problems and formulate contingency plans
Define solutions strategy of significant CSA changes requested by the site whereas minor
administrative changes to be done by local CTS/CRA
Evaluate and identify resourcing needs of SSU staff to be assigned on the project and provide
performance feedback as appropriate
Participate in client, investigator and team meetings
Identify and facilitate CSA training needs of local CTS/ CRA
Maintain and assure quality of work generated
Compile CSA status within a project as agreed with PL and GRO Lead
Prioritize effectively and respond to urgent requests within team or sponsor lead
Provide mentoring and coaching to CTS staff
Resolve negotiation issues that have arisen at the clinical site and escalated from the CTS that
cannot be resolved by the CTS after several attempts.
Escalate changes that fall outside the documented “fall-back” parameters, if available to the Sponsor or to Clinical Site Agreement Manager as appropriate.
Provide internal and Sponsor approval to CTS for signature of the fully agreed CSA according
to applicable PAREXEL or Client instructions
Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP
Guidelines, local regulatory requirements, and PAREXEL WSOPs and study specific procedures
Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims).

Requirements;

Experienced CRA, CTS 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.
Global Site Contract Lead experience.
Excellent computer and internet skills including excellent knowledge of MS- Office products such as Excel, Word
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
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

Education