- Management and oversight of applicable Alexion clinical study registration, including , EuCTR, 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
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Associate Director, Clinical Trial Transparency - Mississauga, Canada - Alexion Pharmaceuticals
Description
This is what you will do:
The Associate Director, Clinical Trial Transparency serves as a subject matter expert and advisor on global transparency needs. This role will ensure that all clinical study registrations and information are accurately routed, tracked, and entered in appropriate databases as per regulatory requirements and in line with Alexion principles, policies, standards, and the law. This role will process clinical documents for anonymization and/or pseudo anonymization in support of Health Canada's PRCI process, EMA policy 0070, EU Clinical Trial Regulation (CTR) and other disclosures of clinical documents that must be redacted or otherwise anonymized to support results posting in public registries and/or any other specific need (eg. publications, synopsis). The role will ensure that the right tools and processes are used to ensure Alexion's assets are effectively protected including our patient confidentially. This position will support the overall Clinical Trial Transparency departmental goals and vision.
You will be responsible for:
You will need to have:
We would prefer for you to have:
Date Posted
25-Apr-2024Closing Date
26-May-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
Associate Director, Clinical Trial Transparency professionals in Mississauga
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Harsh Talajia
Director of Product
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Alexandra Fiodorova
Clinical Trial Associate