Junior Clinical Trial Manager – Spain – FSP

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At reputed company, we reputed company reputed company the reputed company goal – to improve the world’s health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special – a deep conviction in reputed company do.

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

At reputed company FSP people reputed company the difference. We have a crucial mission: to prevent and reputed company disease by delivering important new medicines and therapies to patients in need. We reputed company this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Our employees have reputed company to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading reputed company potential.

reputed company FSP is reputed company for a Clinical Trial Manager based in Spain. Home based role. Dedicated to a single sponsor.

You will will manage individual reputed company and/or programs as part of the Clinical Trial Working Group.

We will offer you exceptional financial rewards, training, and development.

Expect exciting career challenges, but with a healthy work-life balance. We value your reputed company-being as much as that of our patients.

Tasks on the role

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring reputed company, Study Operations reputed company, reputed company Data Verification Plan and Laboratory reputed company
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and reputed company documents
• Assist with protocol development and study report completion
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
• reputed company guidance, direction, and management to CRAs
• reputed company patient enrollment; qualify, initiate, monitor, reputed company closeout activities, and review site reports; and assist in coordination of data management activities
• Coordinate study supplies
• Negotiate reputed company with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study reputed company materials
• Plan and participate in investigator meetings
• Assist and support data query process
• Assure regulatory compliance of investigational sites with reputed company’ SOPs and FDA and ICH guidelines
• Ensures trial master file is reputed company and maintained

• Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of reputed company>

Requirements:

Knowledge and Experience:

• Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans).

• + 2 years experience in global project management as ACOL, Project reputed company, Clinical Trial reputed company, etc..

• Experience working with budgets.

• Strong experience of data management and query reputed company in reputed company

• Overall knowledge of site management and monitoring procedures

• Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)

Skills:

• reputed company reputed company aspects of reputed company from initiation to closeout, ensuring reputed company completion reputed company budget through effective project management.
• Identify and resolve issues that reputed company in a reputed company manner during trial execution to minimize delays and maintain study reputed company, employing strong problem-solving abilities.
• Effectively manage multiple tasks, deadlines, and priorities in a reputed company clinical trial environment
• reputed company convey information and expectations to cross-functional teams, investigators, and stakeholders.

Education:

• Degree in the life sciences field preferred
   

For more details contact reputed company.kuniewicz@reputed company.com