At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.
Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.
Parexel FSP is recruiting for a Clinical Trial Manager based in Spain. Home based role. Dedicated to a single sponsor.
You will will manage individual clinical trials 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 well-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 Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source 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
Provide guidance, direction, and management to CRAs
Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
Coordinate study supplies
Negotiate contracts with vendors of clinical trial services
Review Informed Consent Forms, CRFs, and study related materials
Plan and participate in investigator meetings
Assist and support data query process
Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
Ensures trial master file is current and maintained
Requirements:
Knowledge and Experience:
Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans).
Strong experience as CRA and Lead CRA.
Strong experience of data management and query resolution in clinical trials
Overall knowledge of site management and monitoring procedures
Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
Skills:
Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.
Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.
Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders.
Education:
For more details contact marta.kuniewicz@parexel.com
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