Senior Clinical Trial Manager

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

📋 Description

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

• Manage relationships with external vendors and contract research organizations

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

• Coordinate and take responsibility for the creation of study materials such as CRFs, patient diaries, study participation cards, and source documents

• Support protocol development and the completion of study reports

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

• Provide mentorship, direction, and oversight to CRAs

• Monitor patient enrollment; qualify, initiate, oversee, perform closeout tasks, and review site reports; assist in coordinating data management efforts

• Organize study supplies

• Negotiate contracts with clinical trial services vendors

• Evaluate Informed Consent Forms, CRFs, and related study materials

• Organize and participate in investigator meetings

• Assist and facilitate the data query process

• Ensure regulatory compliance of investigational sites with SOPs as well as FDA and ICH guidelines

• Maintain and keep the trial master file up to date

• Collaborate with external vendors and CROs to ensure efficient clinical trial execution

• Oversee clinical trials from initiation to closeout, ensuring timely completion within budget constraints

• Identify and address issues during trial execution to minimize delays and uphold study integrity

• Manage multiple tasks, deadlines, and priorities in a dynamic clinical trial setting

• 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 involving international trials (Pharmaceutical, Biotech or CRO)

• Demonstrated success with relevant clinical trial experience, including a strong performance record as a CRA in the pharmaceutical field (i.e. biotechnology, pharmaceutical, CRO, medical device)

• Proven expertise in clinical trial management

• Established management/leadership experience in a matrixed environment

• Strong understanding of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes

• Ability to work independently as well as collaboratively within a team setting

• Proficient in MS Office (Word, Excel, PowerPoint, Outlook)

• Excellent verbal and written communication skills coupled with strong organizational capabilities

• Significant experience in clinical trial documentation and processes, including protocols, CRFs, and monitoring plans

• Strong background in data management and query resolution within clinical trials

• Comprehensive knowledge of site management and monitoring procedures

• Bachelor’s degree in nursing or a related field required; science background preferred

• Willingness to work outside of standard hours when business needs arise

🏝️ Benefits

• Competitive salary

• Attractive benefits package

• Comprehensive medical care plan: Health, Dental & Vision coverage

• Life Assurance coverage

• Exceptional work environment

• Collaborative and team-oriented culture

• Access to innovative technology

• Quality training opportunities

• Support for a healthy work-life balance