Site name: bengaluru luxor north tower
Posted date: jun 1 2022
Ready to help shape the future of healthcare?
At gsk, we have already delivered unprecedented change over the past four years, improving r&d, becoming a leader in consumer healthcare, strengthening our leadership, and transforming our commercial executionNow, we’re making the most significant changes we’ve made to our business in over 20 yearsWe’re on track to separate and create two new companies in 2022: new gsk with a leading portfolio of vaccines and specialty medicines as well as r&d based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purposeFor new gsk, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new gsk where outstanding people thrive.
Getting ahead means preventing disease as well as treating itHow we do all this is through our people and our cultureA culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thingSo, if you’re ready to improve the lives of billions, join us at this exciting moment in our journeyJoin our challenge to get ahead together.
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 associate, clinical trial transparency is responsible for supporting the clinical trial transparency teams within each therapy area (oncology, general medicine, specialty, vaccines), for timely and complete delivery of protocol and results summaries, full protocols, reporting and analysis plans and clinical study reports, as required by regulations and policy, for submission to key external registers e.gClinicaltrials.gov, eu clinical trial register and the gsk study registerThe role holder is responsible for providing technical and administrative support to ensure compliance with company policyThe role will report into 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.gProtocol 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 projectsThe 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 updatesEnsure 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, 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:-
O at least 1-2 years of experience in in a pharma/clinical trial environment is an asset
O 1-2 years of experience in an environment associated with clinical trials disclosure and/or of the publishing environment is an asset
O strong communication skills
O experience in process improvement/quality management is an asset
O experience in pharmaceutical company environment and specifically in matrix organization is an asset
Why is this level of experience required - need to understand regulatory guidelines, clinical research and processes, should able to prioritize activities and coordinate with a number of stakeholders
Job-related experience sections above that are required for the job:
Knowledge
O basic scientific, medical, biomedical and/or pharmacist education is clearly an asset.
O prior experience in pharma environment is an asset
O fluent in english, both verbal and written
O advanced it skills (office, document management tools, internet)
Skills
O ability to plan, organize and prioritize workload, to meet deadlines in a global environment.
O strong communication and negotiation skills
O excellent team worker, as well as ability to work autonomously
O able to work and collaborate within teams and networks across functional and geographical boundaries; experience in multicultural settings, diverse environments with respect to dynamics of human interaction
O able to work with defined priorities in a global environment
O act as a role model in line with gsk culture and behaviours
O effective at problem solving and conflict resolution
O good interpersonal relationship skills
Knowledge & application:-
This role requires knowledge and understanding of r&d processes, governance principles as well as an understanding of the regulationGood understanding and interpretation of trial disclosure regulations is critical for the business and it is essential that perspective from the different therapy areas is integrated in to working practicesA key aspect of the job will be to partner with, to interface and to influence key team members (eg: ctt leads, transparency specialists, ctt statisticians, sdls, etc)
Problem solving & innovation:-
Highly complex and unpredictable environment demanding proactive problem-solving skills that require foresight and anticipationThere will also be more reactive issue management which requires analytical thinking to map out plans for resolutionMust be able to quickly assess correct actions to take and carefully weigh multiple optionsMust be able to drive to solutions and provide guidance to the teams as to options and 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)
Success of this role is critical to gsk’s objectives of building trust and transparency with the publicGsk is under close scrutiny for conduct of clinical data disclosure and of share/csr disclosure processesThe 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-culturalAbility to work across cultures and time zones and build effective virtual teams is essentialAdditionally, the corporate cultures of external contractors and providers must also be managed.
Example: gsk policies are applicable worldwide and the role with have to interact with multiple culture and multiple mindset population 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.
At gsk we value diversity (gender, lgbtq +, pwd etc.) and treat all candidates equallyWe aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
Li-gsk
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companiesWe believe that we all bring something unique to gsk and when we combine our knowledge, experiences and styles together, the impact is incredibleCome join our adventure at gsk where you will be inspired to do your best work for our patients and consumersA place where you can be you, feel good and keep growing.
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