Associate Director, Clinical Trial Transparency

4 weeks ago

Boston, United States Alexion Pharmaceuticals, Inc. Full time

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:

* 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.

You will need to have:

* 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

We would prefer for you to have:

* 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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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