Associate Director, Clinical Trial Transparency
Alexion Pharmaceuticals
- Mississauga, ON
- Permanent
- Full-time
- Management and oversight of applicable Alexion clinical study registration, including ClinicalTrials.gov, EuCTR, AlexionClinicalTrials.com and all applicable tracking/routing internally/externally until final execution within the validated system known as TrialScope Disclose.
- Working in a cross-functional, inter-company capacity to ensure compliance is maintained with all legal and regulatory requirements pertaining to any and all applicable clinical studies that are sponsored by the Alexion Group of companies.
- Create anonymized clinical documents following best practices and established SOPs.
- Conduct and/or support team reviews for document anonymization and commercially confidential information in accordance with Health Canada, EMA, and EU CTR guidelines.
- Responsible for triaging information/requests to appropriate functional areas for review and approval and document them systematically for clinical data samples, internal/external data requests, EU CTR, PRCI, and EMA policy 070.
- Involved in the process for clinical data samples and internal/external data sharing requests.
- Provide support to the business in the areas covered by Clinical Trial Transparency.
- Serve and manage the first line of contact for external vendors, including receipt of all Alexion clinical study registrations.
- 8-10 years working in the area of Clinical Trial Transparency
- Demonstrate good communication skills and facilitation skills with the ability to work with others to achieve objectives often in challenging environments
- Masters Degree minimum
- 5-7 years in a role that provided experience with clinical documents, submissions, and understanding of eCTD structure
- Expert user of Clinical Trial Transparency products such as: PharmaCM/Trialscope/Disclose; Instem/BLUR
- Firm understanding of Transparency and Disclosure laws, regulations and policies that will be utilized for this job role
- Ability to maintain and create professional networks with stakeholders
- Experience in managing regulatory health authority GxP Inspections
- High attention to detail and accuracy
- High ethical standards, trustworthy, operating with absolute discretion
- Effective leadership skills
- Relevant experience in a similar role with strong expertise knowledge and experience in Clinical Trial Transparency and Disclosure
- Good analytical, problem-solving and negotiation skills
- Experience in vendor management, including systems, process, and overall relationship as the first line of contact
- Experience in working in a global role
- Experience in process development and implementation
- Ability to track and ensure compliance for multiple regulatory submissions, including maintenance throughout lifecycle of study.
- Cultural awareness and positive attitude in managing change
- Project management experience