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04/05 Kimberlee
HR Manager at GSK

Views:168 Applications:33 Rec. Actions:Recruiter Actions:0

GSK - Manager - Clinical Trial Transparency (6-8 yrs) Premium

Bangalore/Karnataka Job Code: 921178

Are you energized by a clinical education role that allows you to build industry-leading medical capabilities through an integrated professional development framework? If so, this Clinical Support Manager role could be an exciting opportunity to explore.


As a Clinical Support Manager, you will be responsible for working with Education Managers to co-ordinate education operations activities for the learning academy in support of capability development for One Medical and the Continuing Professional Development (CPD) framework.


This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:


- 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.


- 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)).


- 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 reports) to external registers e.g. ClinicalTrials.gov, EU Clinical Trials Register and GSK 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.


- 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


- 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.


- 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.


- 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.


- Drive 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).


- Develop and maintain knowledge and expertise in Data Disclosure environment (Publications and Data Disclosure).


- Partner with key internal stakeholders to strengthen ensure that GSK practices for Policy requirements are in line with relevant internal and external requirements.


Why you?


We are looking for professionals with these required skills to achieve our goals:


- Master's degree - Pharmacy, Chemistry, Bio Engineer, Biology, Medical Doctor, Bio Medical Sciences


- Broad scientific/ pharmaceutical industry background with more than 6 years of experience in clinical research and/or in 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


For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.

Women-friendly workplace:

Maternity and Paternity Benefits

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