INSUD PHARMA
Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous investment in R&D and cutting-edge technology at all our centres.
General Responsibility
The Clinical Quality Specialist will be responsible for ensuring the validation and compliance of eClinical systems, including but not limited to Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), Case Report Forms (CRF), Trial Master Files (TMF), Clinical Outcome Assessments (COA), and electronic Patient-Reported Outcomes (ePRO). This role involves collaborating with cross-functional teams to maintain the highest standards of quality and regulatory compliance.
To collaborate within the Global Quality Unit in creating, implementing, maintaining, and enhancing INSUDPHARMA’ s Clinical Quality System and its business units, including affiliated units, ensuring compliance with applicable guidelines (GCP, GLP/GMP), EMA and FDA/CFR legislation and other applicable regulations/standards.
Specific Responsibilities
* Lead and manage the validation activities for eClinical systems, ensuring compliance with regulatory requirements and industry standards.
* Assist in establishing, implementing, and maintaining the Global/Corporate Clinical Quality Assurance System.
* Provide support for the creation, implementation, and maintenance of a Quality Assurance System across different business units, including affiliated units, within the Insudpharma group.
* Develop and implement quality assurance processes and procedures for eClinical systems. Create and maintain validation documentation, including validation plans, protocols, reports, and standard operating procedures (SOPs).
* Conduct risk assessments and develop mitigation strategies for eClinical systems.
* Lead and conduct qualification and vendor audits of CROs and third-party vendors contracted for clinical trial activities sponsored by the Insud Pharma group, ensuring compliance with applicable Good Practices and relevant regulations
* Collaborate and provide support for external and internal audits, inspections, and vendor qualifications.
* Collaborate on selection and implementation of new Clinical systems. Aid in unifying and maintaining a Global Clinical vendor/service provider Database, including in the qualification process.
* Lead the follow-up on Corrective and Preventive Actions (CAPA) resulting from external and internal audits, including vendor/service provider qualifications.
* Support the maintenance of the Corporate Auditing Management electronical System used for recording audits from opening to closure.
* Provide training and support to staff on CSV processes and regulatory requirements
Requirements and personal skills
* Education: Bachelor’s degree in Life Sciences (e.g. Chemistry, Pharmacy, Biology or Medicine), Computer Science, or a related field. Master is a plus.
* Languages: Fluent English, knowledge of other languages will be an asset.
* Experience (years/area): Minimum of 3-5 years of experience in computer system validation within the pharmaceutical or clinical research industry.
* Specific Knowledge: Strong understanding of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5, 21 CFR Part 11) related to CSV.
* Travels: Travel up to 30% to clinical research units, Biolabs and other company locations as required.
* Personal Skills: Excellent analytical, problem-solving, and communication skills. Proficiency in using eClinical systems and quality management software. Accuracy and reliability, proactivity, adaptability/flexibility and organizational skills are essential.