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

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

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:

• Degree in the life sciences field preferred
  

For more details contact marta.kuniewicz@parexel.com