[OKE-00] - Clinical Contracts Analyst

[OKE-00] - Clinical Contracts Analyst

29 ott
|
ExecuPharm
|
Italia

29 ott

ExecuPharm

Italia

For our European operations ExecuPharm (Parexel Company) is currently looking for a Clinical Contracts Analyst who would perform their job responsibilities from their home office in Europe.





The CCA will be rewarded with a permanent role dedicated to one Sponsor-prestigious Biopharmaceutical Company with a strong Oncology products portfolio. They will receive competitive salary package combined with benefits, they will also gain a chance to progress within the Organisation.





The Clinical Contracts Analyst will be an integral member of the Clinical Development Operations (CDO) department, assisting with the entire life cycle of contracts activities,

developing and negotiating clinical site budgets and conducting business operations as detailed below.





DETAILED DUTIES & RESPONSIBILITIES TYPICALLY INCLUDE:





- Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global Trials

- Serve as legal liaison for clinical contract requests such as, NDA’s, CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal group

- Process all clinical contract requests and help facilitate early execution through the Contract Management System

- Perform consistent quality audits of work output and document knowledge base as needed

- Maintain accurate contract metrics on an ongoing basis.

- Serve as primary contact for the Sponsor during contract negotiation phase

- On-going interface with sites and vendors regarding contractual issues during the lifetime of the contract

- Establish and maintain direct site and vendor contact

- Negotiate Clinical Site Contracts & Budgets





For Sites Managed by the Sponsor:



- Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract

- Work closely with study teams to develop a budget template tailored for each study

- Negotiate and manage consistent site budgets that will assist in early site activation

- Respond to queries related to contracts and budgets

- Manage the contract escalation process to appropriate individuals, as needed

- Establish good customer relations with sites starting with the primary point of contact for budgets and contracts





For Sites Managed by a CRO:



- Review and approve the investigator fee template per country for each study before distribution to sites

- Be a conduit for the contract request to the Sponsor's team for initial contract request through execution for contracts handled by a CRO and track the contract process for each study with a CRO;

- Serve as escalation point of contact for budget escalations from CRO;

- Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Sponsor's standards





Other



- Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.

- Participate in the development and testing of tools and procedures

- Workflow management





QUALIFICATIONS:



- Bachelor’s degree in Life Science, Business or equivalent

- Experience in contract management, proposal development or related field

- Intermediate Excel and database management skills

- Knowledge of ICH/GCP in the provision of clinical trials

- Excellent negotiation skills

- Highly organized with excellent oral and written communication skills

- Work both independently and as part of a team





For an immediate consideration, please send your CV to the job poster. We look forward to hearing from you!



Show moreShow less

Puoi trovare l'offerta di lavoro originale su Kit Lavoro:
https://www.kitlavoro.it/lavoro/18980816/oke-00-clinical-contracts-analyst-italia/?utm_source=html

Candidati a questo annuncio

Mostra le tue capacità professionali all'azienda, compila il form e lascia un tocco personale nella lettera di presentazione, aiuterà il recruiter nella scelta del candidato.

Iscriviti a questa job alert:
Inserisci il tuo indirizzo email, ti consentirà di essere sempre aggiornato sulle ultime offerte di lavoro per: [oke-00] - clinical contracts analyst
Pubblica un nuovo annuncio gratuito
Hai bisogno di pubblicare un annuncio? Con oltre 1 milione di utenti unici al mese in breve troverai il candidato ideale per la tua Azienda, cosa aspetti!
Pubblica adesso

Iscriviti a questa job alert