Global Site Contract Specialist
hace 2 días
Parexel International is a leading biopharmaceutical services provider that improves the world's health by transforming scientific discoveries into new treatments. With a commitment to quality, respect, empowerment, and accountability, we believe in our values and strive to deliver excellence in every aspect of our business.
We are seeking a German-speaking Global Site Contract Specialist based in the EMEA region to join our team. This role will be responsible for negotiating study-specific generic and country Clinical Site Agreement (CSA) templates with sponsors and supporting the project lead in the negotiation of country budgets. Additionally, the successful candidate will manage CSA activities, liaise with the project lead, GRO lead, and sponsor to ensure that CSA start-up deliverables are met, and coordinate local CTS/CRA working on CSAs on a project level.
The key accountabilities of this role include:
- Acting as a functional specialist on projects and developing study-specific CSA strategies
- Agreeing and negotiating study-specific generic and country CSA templates with sponsors
- Supporting the project lead in the negotiation of country budgets with sponsors
- Gathering relevant study information from the project lead
- Discussing and finalizing specific country CSA templates with input from sponsors, project leads, and GRO leads if appropriate
- Upon sponsor approval of the country-specific template, storing the final approved and complete country template and country budget PMED
- Communicating CSA strategies, CSA turnaround timelines, CTMS tracking requirements, and budget information/updates with assigned CTS/CRAs
- Providing agreed study and country CSA templates to local CTS/CRA for country-specific adaptation
- Coordinating interaction between GRO leads, project leads, and sponsors, including overall timeline management for CSAs
- Coordinating overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/PL
- Providing updates about template amendments, process changes, investigator fees, local requirements, etc., to ensure that relevant CSA databases are up-to-date
- Maintaining comprehensive language trackers
- Early recognition of areas of potential problems and formulating contingency plans
- Defining solutions strategies for significant CSA changes requested by sites, whereas minor administrative changes are done by local CTS/CRA
- Evaluating and identifying resourcing needs of SSU staff to be assigned on the project and providing performance feedback as appropriate
- Participating in client, investigator, and team meetings
- Identifying and facilitating CSA training needs of local CTS/CRA
- Maintaining and assuring quality of work generated
- Compiling CSA status within a project as agreed with PL and GRO Lead
- Prioritizing effectively and responding to urgent requests within teams or sponsor leads
- Providing mentoring and coaching to CTS staff
- Resolving negotiation issues that have arisen at clinical sites and escalated from CTS that cannot be resolved by CTS after several attempts
- Escalating changes that fall outside documented 'fall-back' parameters, if available, to sponsors or to Clinical Site Agreement Managers as appropriate
- Providing internal and sponsor approval to CTS for signature of fully agreed CSAs according to applicable PAREXEL or client instructions
- Maintaining a working knowledge of and ensuring compliance with applicable ICH-GCP guidelines, local regulatory requirements, and PAREXEL WSOPs and study-specific procedures
- Completing routine administrative tasks in a timely manner (e.g., Timesheets, metrics, travel expense claims)
This role requires:
- Experience as a CRA, CTS, or 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
- Show commitment to and perform consistently high-quality work
- Ability to identify and address issues proactively in a timely manner
- Ability to take initiative, work independently, and delegate
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 and German languages are essential
Estimated salary: $70,000 - $90,000 per year, depending on experience and qualifications.
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