Clinical Trial Posting Manager

Wodker Associates; Barcelona; On-site; EUR 60,000 - 90,000; Full time

Job summary

Wodker Associates in Barcelona, Spain, seeks a CTP Manager to oversee disclosure of clinical trial information across registries and public websites, ensuring compliance with internal rules and external guidelines. You will develop and update the disclosure strategy, perform QA checks, and coordinate data collection and posting on company sites, with emphasis on accuracy and regulatory adherence.

This role requires an advanced degree in Medicine or Life Sciences and 2–3 years in trial

Qualifications

• Advanced degree in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience.
• Min. 2 - 3 years experience in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials.
• Advanced understanding of global legislations, regulations and guidelines.
• Advanced understanding of ICH/GCP regulations.
• Strong English language skills, fluent speaking mandatory.
• Advanced knowledge of the co product and development portfolio.
• Solid understanding of cross-divisional business requirements of R&D functions and other internal customers.

Responsibilities

• Disclose clinical trial information on registries and websites with accuracy and timeliness.
• Ensure QA of disclosed information per internal processes.
• Monitor and update disclosure strategies to meet evolving laws and guidelines.
• Check for promotional language and internal compliance in disclosures.
• Coordinate data collection and posting across platforms.

Skills

Clinical trial disclosure

Regulatory compliance

Quality Assurance

Project management

English proficiency

Education

Advanced degree in Medicine

Life Sciences degree

Tools

Clinical Trial Management Systems

Workflow Management Systems

Job description

We are looking for a CTP Manager to work in a multinational company. Its products and services are designed to benefit people and improve their quality of life.

Position purpose:

• Manage and publicly disclose clinical trial information into clinical trial registries and posting of clinical trial result summaries on company owned and public international websites based on internal rules and external guidelines, obligations, and legislations for the entire internal product portfolio, including regular updates and maintenance of the disclosed information according to internal and external requirements
• Contribute to the development and continuous update of company’s disclosure strategy for clinical trial information based on cross functional internal requirements and the rapidly changing external legal and regulatory requirements, industry commitments and obligations
• Disclose information on company’s Clinical Trials at high level quality by fully complying to the related Quality Assurance processes

Key tasks:

• Trigger timely insurance for clinical trials based on business requests by following the internal Clinical Trial Insurance
• Collection of the necessary data for public disclosure of clinical trial information: design forms/templates, request information, track responses, disclose information
• Provide up to date and consistent Clinical Trial Posting data on all required company owned and public websites
• Formal quality control of publicly disclosed clinical trial information according to the QA process established
• Check consistency of disclosed information for a study, i.e. consistency of disclosed information on different internet sites and of registry and results information for the same study
• Check disclosed information for inappropriate wording, especially for promotional language
• Check compliance to internal disclosure process and to external legislations and obligations
• Contribute to continuous monitoring for changing and new Clinical Trial Posting requirements to keep the Global Development Management up to date and to adjust and update internal rules and processes accordingly
• Advanced degree in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience.
• Min. 2 - 3 years experience in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials.
• Advanced understanding of global legislations, regulations and guidelines; Strong ability to understand and comply to complex legislations and regulations.
• Advanced understanding of ICH/GCP regulations.
• Advanced understanding of drug development process over different stages.
• Advanced understanding of IT processes and Systems used in Clinical Development, especially Clinical Trial Management Systems, Document and Workflow Management Systems.
• Strong skills in English language, both oral and written (fluent speaking mandatory).
• Advanced knowledge of the co product and development portfolio.
• Solid understanding of cross-divisional business requirements of R&D functions and other internal customers.
• Advanced written and oral communication skills; Advanced understanding of company’s general communication policy to the public, to Health Authorities and to Regulatory Bodies.
• Advanced project management and project leadership skills.
• Good ability to manage resources smartly and to do things simply and effectively.
• Good ability to think and act with customers in mind.
• Good ability to overcome complexity and to provide oversight.