job title: Associate tranparency specialist(gsk)

Roles and Responsibilities

Key Responsibilities -

• Preparation of clinical documents for anonymization.

• Anonymization of clinical documents in accordance with GSK written standards. Ensure proper documentation and oversight of all business processes, standard procedures and work instructions related to document anonymization capability ensuring compliance with regulatory requirements.

• Oversight of vendor and offshore service providers supporting the document anonymization and data sharing process.

• Coordinate business relationships with external vendors to ensure simple and efficient models for anonymizing clinical documents, and for delivering quality, on time and in line with GSK expectations.

• Monitoring the quality of information received from document anonymization partners through quality control and assurance efforts.

• Maintaining a strong relationship with external and internal business partners, communicating and driving to resolution issues hindering the disclosure of clinical documents, ensuring delivery to agreed timelines and priorities.

• Contribute to the development of procedural documentation including guidance documents and / or instructional documents.

• Contribute to the development and delivery of training material for document anonymization.

• Contribute to efforts to ensure quality and consistency of anonymization standards and storage of clinical documents in R&D.

Basic Qualifications -

• At least 4 years of experience in document anonymization, regulatory requirements, stakeholder management.

• Understanding and prior experience in anonymisation of clinical documents for EMA Policy 0070 and Health Canada PRCI (preferred)

• Master's degree in life sciences.

• Experience in managing clinical trial (study, data, or system/technology) activities.

• Good understanding of clinical trial lifecycle, clinical trial metadata [i.e. information about the trials], clinical trial data [i.e. observed data collected as part of the trial], clinical documents.

Good to have

• Good understanding of R&D and the clinical development process to enable understanding of anonymization related activities, manage risks and, where required, develop novel solutions and processes.

• Good overview and understanding of end to end study process and data flow; in-depth knowledge of patient data – a recognized expert.

• Ability to bridge the communications gap between scientific/medical and non-scientific organizations. Ability to communicate the importance of relevant technical or process solutions to business problems. Provide personalized communications with reasons and rationale, context and relevance of the thinking. Describe anonymization in a way that can be understood by the Business.

• Excellent verbal and written communication skills.

• Ability to work with a high degree of independence.

• Excellent attention to detail.

• Good teamwork and interpersonal skills with demonstrated ability to interact effectively across boundaries with other global functions using influencing and relationship building skills.

• Ability to effectively manage conflicting demands in a high pressure, constantly changing environment and still achieve timely delivery

• Awareness of medical writing, publishing and regulatory processes and associated deliverables. Experience of reviewing clinical documents is an advantage.