Clinical Trial Transparency Specialist
Warszawa Clinical Trial Transparency Specialist
Warszawa
NR REF.: 1092337
About us
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. The role This role will ensure that all Clinical Study Registrations, Updates and Clinical Study Results and Information/Data Requests are accurately routed, tracked and entered into appropriate databases as per Regulatory Requirements and in line with AstraZeneca principles, policies and standards. The role will advise customers on how to access and retrieve information and data, and seek to maximize the value from information by integrating people, processes and technologies. The role will ensure that the right tools and processes are used to ensure AstraZeneca’s assets are effectively protected.
Key accountabilities
Skills & experience
Essential:
Desirable:
Benefits:
We offer stable employment conditions, wide benefit package and the opportunity to participate in building a new team.
Warszawa
NR REF.: 1092337
About us
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. The role This role will ensure that all Clinical Study Registrations, Updates and Clinical Study Results and Information/Data Requests are accurately routed, tracked and entered into appropriate databases as per Regulatory Requirements and in line with AstraZeneca principles, policies and standards. The role will advise customers on how to access and retrieve information and data, and seek to maximize the value from information by integrating people, processes and technologies. The role will ensure that the right tools and processes are used to ensure AstraZeneca’s assets are effectively protected.
Key accountabilities
- Management and oversight of applicable AstraZeneca Clinical Study Registrations and Results, including ClinicalTrials.gov, EudraCT, AZCT.com and all applicable tracking/routing internally/externally until final execution within the validated system known as PharmaCM.
- Responsible for triaging Information/Data Requests to appropriate functional areas for review and approval and document process in applicable database(s).
- 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 AstraZeneca Group of companies.
- Along with other team members, proactively monitors the review and approval of Clinical Study Registrations, Results and Data Requests within the applicable database(s). Responsible for sending reminders and promoting the timely completion of reviews and approvals.
- Serves and manages the first line of contact for receipt of all AstraZeneca Clinical Study Registrations and Results submitted for review and approval from the applicable governmental agencies, study teams, and others.
- Professionally represents the group in response to external and internal queries for report and metrics requests.
- Works collaboratively with other team members to update and maintain all databases used for Clinical Trial Transparency processes.
- Responsible for supporting/demonstrating compliance with established corporate standards.
- Review and contribute to departmental procedure documents related to Clinical Trial Transparency
- Supports System updates to all CTT Systems
Skills & experience
Essential:
- Prior relevant experience in a similar role with good knowledge and experience in Clinical Trial Disclosure
- Excellent written and verbal communication skills in English
- Demonstrate good communication skills and facilitation skills with the ability to work with others to achieve objectives
- Working knowledge of drug development process and associated government regulations, ICH and GCP
- Demonstrated aptitude for process and technology
- Demonstrated ability to work collaboratively in a team environment as well as independently; proven ability to facilitate team building and team work
- Excellent negotiation, collaboration, interpersonal, problem solving and conflict resolution skills
- Demonstrated ability to set and manage priorities, resources, goals and project initiatives
- Ability to function in a team environment as well as ability to function independently
- Customer Focused and Performance Driven
Desirable:
- Experience in systems management
- Experience of working in a global organization with complex/geographical context
- Proven Conceptual and Analytical thinking; concern for standards and willingness to learn from others
- Invites input from each person, shares ownership and visibility; creates a climate of collaboration, performance and add value to the business
- Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement
Benefits:
We offer stable employment conditions, wide benefit package and the opportunity to participate in building a new team.
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