Clinical Trial Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee individual oncology clinical trials and/or programs as part of the Clinical Trial Working Group.

• Manage relationships with external vendors and contract research organizations.

• Develop study documents including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.

• Coordinate and take charge of designing study materials such as CRFs, patient diaries, study participation cards, and source documents.

• Assist in the development of protocols and completion of study reports.

• Supervise monitoring activities, which may include routine on-site clinical monitoring at clinical study sites to ensure compliance with GCPs, SOPs, and study protocols.

• Provide guidance, direction, and management to Clinical Research Associates (CRAs).

• Monitor patient enrollment; qualify, initiate, oversee, conduct closeout activities, review site reports, and aid in data management coordination.

• Coordinate the logistics of study supplies.

• Negotiate contracts with vendors providing clinical trial services.

• Review Informed Consent Forms, CRFs, and other study-related documentation.

• Plan and engage in investigator meetings.

• Support the data query process.

• Ensure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines.

• Maintain and keep the trial master file up-to-date.

• Collaborate in managing external vendors and CROs to guarantee efficient execution of clinical trials.

• Oversee clinical trials from initiation to closure, ensuring they are completed on time and within budget.

• Identify and resolve issues related to trial execution to minimize delays and uphold study integrity.

• Manage multiple tasks, deadlines, and priorities within a complex clinical trial environment.

• Effectively communicate information and expectations to cross-functional teams, investigators, and stakeholders.

⛳️ Requirements

• A minimum of 5 years of industry experience in clinical trial project management across international trials (Pharmaceutical, Biotech, or CRO).

• Ability to collaborate across teams with clear communication skills.

• Patient-focused mindset with a strong attention to detail.

• Demonstrated experience in clinical trials, including a proven track record as a CRA in the pharmaceutical industry (i.e., biotechnology, pharmaceutical, CRO, medical device).

• Proven expertise in clinical trial management.

• Demonstrated management and leadership experience in a matrixed environment.

• Working knowledge of GCP, ICH guidelines, regulations, regulatory requirements, and clinical trial processes.

• Ability to work independently as well as part of a team.

• Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook).

• Excellent oral and written communication skills paired with strong organizational capabilities.

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

• Extensive experience in data management and query resolution within clinical trials.

• Comprehensive understanding of site management and monitoring procedures.

• Bachelor's degree, nursing degree, or equivalent required; science degree preferred.

• Work schedule may require flexibility, including working outside standard hours to meet business needs.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Medical care plan: Health, Dental & Vision.

• Life Assurance coverage.

• Outstanding work environment.

• Culture promoting teamwork and collaboration.

• Access to innovative technology.

• Exceptional training opportunities.

• Healthy work-life balance.