Pharma Clinical Trial Transparency Job @ GSK – Apply Online
GSK hiring Clinical Trial Transparency manager. Manager job opening 2022. Clinical Trial Transparency job opening 2022, Pharmacy and chemistry job opening 2022, M Pharmacy job opening 2022, MSc Chemistry job opening 2022, Chemistry job opening 2022. Check out all the details on the same below:
Job Title: Manager – Clinical Trial Transparency
Location: Bengaluru, India
Department: Medical and Clinical
Id: 341849
Knowledge/Education Required:-
Minimum Level of Education Required – University Scientific Degree, Master or equivalent professional experience
Preferred Level of Education – Phd
Area of Specialization – Pharmacy, Chemistry is an asset
Why is it required:-
- Need to understand the science behind the documents (protocol/results summaries/ study reports) (be able to participate in specialized scientific discussions)
- Â Need to be able to acquire knowledge in an independent and fast manner (Dependable self-starter).
- Â Need to be able to handle complex governance questions in a corporate setting.
Previous Experience Required:-
Minimum Level of Job-Related Experience Required:-
- Broad scientific/ pharmaceutical industry background with more than 6 years of experience in clinical research and/or in the pharmaceutical industry.
- Proficiency in GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)
- Knowledge of PhRMA/EFPIA principles of clinical trial disclosure, and related best practices
- Experience with Clinical Trial Disclosure software solution(s)
- Knowledge of GSK clinical/EPI/HE development activities and GCP Guidelines.
- Proven experience of managing and driving complex transversal projects involving senior management
- Previous experience to implement change management projects.
- Previous line management and matrix team experience is essential.
Why is this level of experience required:-
The job-holder will interact with many different functions across GSK as well as with external stakeholders; position holder needs to understand intimately the business needs and operating environment across the entire development organization; legislation is complex and continually evolving.
Job-Related Experience sections above that are required for the job:-
- Significant knowledge and understanding of R&D environment, policies and procedures and applicable regulated disclosure requirements.
- Strong understanding of GSK Organization strategy. Able to make links within GSK organization.
- Ability to incorporate strategy & organizational considerations and to operationalize them.
- Proven sense of urgency.
- Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills.
- Promotes motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
- Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment.
- Self-motivated with the ability to work independently, to develop credibility with colleagues within iGSK.
- Act as a role model in line with GSK core values and behaviors.
- Comfortable to evolve in changing and challenging environment.
Knowledge & Application:-
Establish, roll-out and promote a consistent process for data disclosure activities throughout therapy area. This role requires a thorough knowledge and understanding of R&D organization, policies, and governance principles as well as an understanding of the regulation in this area to ensure all GSK R&D staff, contractors and suppliers involved in Policy activities, are fulfilling their duties ensuring the highest standards.
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 into CMO to achieve appropriate external engagement, ensure 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 Manager, Clinical Trial Transparency, is responsible for leading and driving end to end data transparency within each therapy area (Oncology, Specialty, Vaccines), through capability development, governance and compliance and directing the core delivery team to ensure consistent, timely and complete delivery of protocol and results summaries, full protocols, reporting and analysis plans and clinical study report synopses, 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 objective is to establish, roll-out and promote consistent process for disclosure activities throughout the global organization and ensure oversight for maintenance and improvement of processes for public disclosure function according to evolving requirements. The role will report into the Operations Head, Clinical Trial Transparency.
Job Purpose:-
The purpose of the role of the Manager, Clinical Trial Transparency is to drive the delivery of activities related to data disclosure in GSK R&D in the respective therapy area (Oncology, Specialty, Vaccines). The role is accountable to ensure consistent, timely and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results 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 and drive the operational delivery of current and future transparency commitments (e.g. plain language summaries). The role holder will need to make judgment calls to apply policy and practice recommendations to complex situations involving multiple internal stakeholders. The role is responsible to maintain the standards to highest level for data accuracy through the scrupulous respect of an established, auditable process, and communication of process to all involved players. The role holder will have to combine project management and governance aspects in a matrix environment.
Key Responsibilities:-
1. Drive end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing. Serve as a single-point of contact for project teams and functional matrix teams for questions related to Data Disclosure.
2. Assess studies for disclosure and patient level data sharing requirements and guide study teams through the achievement of complete, consistent and timely disclosure and listing of studies in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register and Data sharing websites (such as Clinical Study Data Request (CSDR)).
3. Ensure timely, consistent and accurate delivery of data disclosure artefacts (e.g. protocol and result summaries, full protocols, reporting and analysis plans and clinical study report synopses) to external registers e.g. ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Collaborate with a team of recognized subject matter experts to ensure quality of output. Work with outsourced resources (platforms, consultants) to ensure resources to address workload beyond FTE capabilities.
4. Supervise and monitor delivery of the documents amongst the different Service providers involved. Coordinate workload distribution and establish/ maintain a robust communication interface across all people involved in the delivery of the documents. Act as primary point of contact for service provider(s). Monitor CRO performance. Supervise quality of output delivered by individual members of the team
5. Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into GSK’s Clinical Trial Disclosure and Transparency strategy.
6. Promote consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements.
7. Proactively identify business transparency risks and propose and implement strategies to manage the implications of these risks on the business. Support risk management framework implementation, including risk identification, assessment and prioritisation and the definition of mitigation plans.
8. Drive compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g. Transparency Dashboard).
9. Contribute to the development of training material for the business, clinical support services and service provider(s).
10. Develop and maintain knowledge and expertise in the Data Disclosure environment (Publications and Disclosure). Partner with key internal stakeholders to strengthen ensure that GSK practices for Policy requirements are in line with relevant internal and external requirements.
Apply Online
Editors Note: Pharma Clinical Trial Transparency, Pharma Clinical Trial Transparency, Pharma Clinical Trial Transparency Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
