GSK Life Sciences, Biology & Biochem Clinical Trial Transparency Associate Job

GSK Clinical Trial Jobs For Biology, Biochem & Life Sciences

GSK Clinical Trial Jobs For Biology, Biochem & Life Sciences. GlaxoSmithKline Clinical Trial Transparency Associate job opportunities. Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Clinical Trial Transparency. Check out all of the details below –

Name of the Position – Clinical Trial Transparency Associate

Locations – Bangalore, India

Categories – Medical and Clinical

Req ID – 338146

The rationale for Review

As part of the GSK Future Ready program, the R&D Bioethics, Risk Management and CMOs office was created with direct reporting to CMO to achieve appropriate external engagement, ensure the highest standards of Medical governance and comply with regulations in multiple areas of intense focus and scrutiny such as Research practices, Data disclosure and Non-promotional engagement.

The Associate, Clinical Trial Transparency is responsible for supporting the Clinical Trial Transparency teams within each therapy area (Oncology, General Medicine, Specialty, Vaccines), for the timely and complete delivery of protocol and results in summaries, full protocols, reporting and analysis plans and clinical study reports, as required by regulations and policy, for submission to key external registers e.g. ClinicalTrials.gov, EU Clinical Trial Register and the GSK Study Register. The role holder is responsible for providing technical

and administrative support to ensure compliance with company policy. The role will report to the Operations Head, Clinical Trial Transparency.

Job Purpose

The purpose of the role of the Associate, Clinical Trial Transparency is to support the delivery of activities related to clinical trial data disclosure in GSK R&D in the respective therapy area (Oncology, General Medicines, Specialty, Vaccines). The role is responsible to provide technical and administrative support for the timely and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results in summaries, full protocols, reporting and analysis plans and clinical study reports, and patient-level data, ensuring ethical and transparent disclosure of data in compliance with GSK Policy on Disclosure as well as external regulations in collaboration with a multidisciplinary team of experts across projects. The role will support the implementation of new processes to meet regulatory requirements related to transparency of clinical studies and other data disclosure deliverables

Key Responsibilities

• Support the operationalization of public disclosure requirements by coordinating the administrative/technical and nonscientific process for the delivery of disclosure content.
• Ensure maintenance of CTT timeline and workload planning/tracking tools, their timely updates and communication with Therapeutic area teams to support on-time delivery of CTT activities
• Collaborate with team members internal and external to CTT to receive and share clinical study-level information (eg: study status reports, Issue reports from public registers, study data maintenance reports from Disclosure systems) that are critical to CTT delivery.
• Support CTT Leads in the Disclosure maintenance updates to Regulated public registers (Clinicaltrials.gov, EU PAS Register) via the Disclosure system
• Work in close collaboration with other functional representatives to track cross-functional input for key CTT delivery
• Update Disclosure systems for regular study-level updates. Ensure archival of final records in applicable systems for the posting of the documents on the required registries.
• Ensure compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g Transparency Dashboard).
• Contribute to the development of training material for the business, clinical support services and service provider(s).
• Ensure proper documentation and archival support, timely implementation of audit findings and observations
• Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK’s Clinical Trial Disclosure and Transparency processes.

Knowledge/Education Required

Minimum Level of Education Required – Bachelor’s Degree in life science, biology, chemistry, biochemistry, pharmacology, pharmacy, or other relevant experience

Preferred Level of Education –Master’s degree

Area of Specialization – Life sciences, biology, chemistry, biochemistry, pharmacology, Pharmacy, Clinical Research

Why is it required – Need to understand the business principles and processes of CTT and be able to acquire knowledge in an independent and fast manner

Previous Experience Required –

Minimum Level of Job-Related Experience Required –

• At least 1-2 years of experience in a Pharma/clinical trial environment is an asset
• 1-2 years of experience in an environment associated with Clinical Trials Disclosure and/or the publishing environment is an asset
• Strong communication skills
• Experience in process improvement/quality management is an asset
• Experience in a Pharmaceutical company environment and specifically in a matrix organization is an asset

Why is this level of experience required – Need to understand Regulatory guidelines, clinical research and processes, should be able to prioritize activities and coordinate with a number of stakeholders

Job-Related Experience sections above that are required for the job –

Knowledge

• Basic scientific, medical, biomedical and/or pharmacist education is clearly an asset.
• Prior experience in a Pharma environment is an asset
• Fluent in English, both verbal and written
• Advanced IT skills (Office, Document management tools, Internet)
  

Skills

1. Ability to plan, organize and prioritize workload, to meet deadlines in a global environment.
2. Strong communication and negotiation skills
3. Excellent team worker, as well as ability to work autonomously
4. Able to work and collaborate within teams and networks across functional and geographical boundaries; experience in multicultural settings, and diverse environments with respect to dynamics of human interaction
5. Able to work with defined priorities in a global environment
6. Act as a role model in line with GSK culture and behaviours
7. Effective at problem-solving and conflict resolution
8. Good interpersonal relationship skills

Knowledge & Application

This role requires knowledge and understanding of R&D processes, and governance principles as well as an understanding of the regulation. Good understanding and interpretation of trial disclosure regulations are critical for the business and it is essential that perspective from the different therapy areas is integrated into working practices. A key aspect of the job will be to partner with, interface and influence key team members (eg: CTT Leads, Transparency Specialists, CTT Statisticians, SDLs, etc)

Problem Solving & Innovation

A highly complex and unpredictable environment demands proactive problem-solving skills that require foresight and anticipation. There will also be more reactive issue management which requires analytical thinking to map out plans for resolution. Must be able to quickly assess correct actions to take and carefully weigh multiple options. Must be able to drive to solutions and provide guidance to the teams as to options and the best path to take.

Interaction

Ability to interact effectively across boundaries and functions using influencing, relationship building skills and good communication skills.

Interfaces within GSK – influences partner departments based globally (Clinical, Epidemiology, etc.) and in Regions/LOCs – Regional Study Managers)

The success of this role is critical to GSK’s objectives of Building Trust and Transparency with the public. GSK is under close scrutiny for the conduct of clinical data disclosure and of SHARE/CSR disclosure processes. The role requires the ability to build cooperative and collaborative relationships within a matrix environment within CTT and across related groups within GSK.

Multi-Cultural Requirements

• Multicultural: the role will be global to an extent, working across geographies, and multi-cultural. The ability to work across cultures and time zones and build effective virtual teams is essential. Additionally, the corporate cultures of external contractors and providers must also be managed.
  
• Example: GSK Policies are applicable worldwide and have the role of having to interact with multiple cultures and multiple mindset populations to ensure common understanding and implementation of the policy standards.
• Impact – Within R&D and Medical – The role will provide technical/administrative support on disclosure requirements in the assigned project.

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