Associate Site Start-Up Team Lead, Lisbon (Portugal)

A World's leading Pharmaceutical Services Company is looking for an Associate Site Start-Up Team Lead to ensure fast patient recruitment and start-up for both local studies and complex multi-site, multinational studies.
This position is ideal for those interested in specializing in the key area of setting-up clinical trials.

Responsibilities:
The successful candidate will work in an international environment gaining greater knowledge in Clinical Trial Agreements, Site Identification, Ethics and/or Core Documents, being able to serve as Study Start-up Lead in different projects or programs, in close collaboration with Clinical Department and Regulatory Affairs.
*Serve as Site Start-Up (SSU) lead within a country or region for projects or service line.
*Maintain and manage SSU data tracking entries in database.
*Review and provide feedback to management on site performance metrics.
*Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for startup. Review and negotiate regulatory documents, contracts, and contract amendments with sites and sponsors for agreement on wording and budgets.
*Resolve site issues and determine status for product shipment.
*Work with regulatory team members or sponsor to secure authorization of regulatory documents.
*Work with legal team members or sponsor to secure authorization of contracts.
*Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
*Where applicable, provide work instructions to team members in preparation of regulatory submissions.
*May participate in feasibility and/or site identification activities.

Skills:
*Life Science Degree
*Minimum 3 year experience of working in a clinical research related environment
*Interest in specializing in Contracts, Site Identification, Ethics and Core Documents
*In-depth knowledge of clinical systems, procedures, and corporate standards
*Strong knowledge of medical terminology and regulations
*Broad knowledge of clinical research
*Strong knowledge of Microsoft Office and e-mail applications
*Effective communication, organizational, and interpersonal skills
*Ability to work independently and to effectively prioritize tasks
*Ability to delegate effectively
*Attention to detail
*Ability to work within tight timelines with high quality standards
*Fluent in Portuguese and in English, both written and verbal.

My client offer career opportunities providing flexibility and growth across the organisation with high international projection, competitive salary and benefits package, work-life balance initiatives and social events.

For a confidential consultation call Esther Manrique on 0044 (0) 207 255 6665 or email your CV to [Email hidden]
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