GSK - Manager - Data Sharing - Clinical Research

Would you like to enhance your clinical systems expertise with an opportunity to accelerate compliance and efficiency across clinical operations? If so, this Clinical Support Manager role could be an excellent opportunity to explore.

The Manager - Data Sharing is responsible for management of patient level data sharing of GSK's studies through external multi-sponsor site by managing requests made via the external portal, checking that enquiries and research proposals received via the portal are complete, and maintain highest-level of oversight of all requests. This will involve managing the SHARE Request system to review and respond to requests from researchers and managing enquiries (including off-line requests).

This role requires a good understanding of the policy requirements around data disclosure and data sharing as well the ability to work with a wide network of individuals to ensure the numerous data sharing requests are processed correctly and in a timely manner to meet the externally committed timelines consistently. This role will ensure that researchers who have been provided access to GSK data and information are adequately supported and any questions they have are addressed.

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

- Manages the queries and data requests for anonymized patient level data from GSK clinical studies on external data sharing portal (e.g. CSDR, Vivli) by external researchers for GSK patient level data. Assesses the feasibility of listing the study according to the - Review criteria for enquiries- on the external portal. This assessment includes confirming availability of study data and documents and as needed requesting Legal review for any restrictions on data sharing applicable to the study).

- Ensure processes implemented for Proposal tracking to track the progress of requests through the process of data/document availability, data anonymisation and document redaction, signed Data Sharing Agreement, data and document transfer and account set up process. Ensure appropriate mechanisms to track feasibility evaluations and raise issues for discussion and resolution.

- Ensure data & documents are transferred and accounts are set up for the researchers to work in the Data Access System.

- Work with the Data Access System Vendor and drive all Access System support issues raised by the researchers to resolution, ensuring that an efficient and robust support model is in place to meet the needs of the researcher.

- Coordinate transfer of agreed data and information to the researchers via the Data Access System, ensure all researchers have a signed a data-sharing agreement prior to providing access to data, ensure that data and relevant documents are in the Transparency Repository and where necessary follow up with those responsible within GSK for providing the information.

- Ensure documentation (e.g. proposals, feasibility forms, data sharing agreements, correspondence) are appropriately archived upon completion of each request.

- Ensure researchers are regularly updated of progress and escalate issues/bottleneck as appropriate, including applying the necessary checks prior to escalation to the Director.

- Verify clinical study data prior to anonymisation to ensure that the correct data is provided to the research teams and provide any necessary supporting documentation to facilitate data reuse.

- Drive delivery of KPIs and input into the collection of metrics for reporting and workload management. Set prioritisation to manage the delivery of anonymised data and redacted documents to expected timelines. Provide issues resolution to ensure the end-to-end business process is defined and implemented correctly & consistently so that key timelines for providing access are adhered to.

- Develop and refine the approach, proactively identifying risk and areas for process improvement for data sharing process.

- Maintain an in-depth knowledge of data sharing requirements and contribute to industry collaborations/discussions on data access. Ensures that GSK expertise and practices for patient level data sharing are in line with relevant internal and external best practices.

Why you?

Basic Qualifications :

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

- Master's Degree in science

- Knowledge and awareness of clinical research especially clinical documents, data sharing landscape, strong understanding of clinical data flow across the clinical development process, basic understanding of data anonymization and/or de-identification.

- At least 6 years of experience in clinical research, and activities related to data re-use and sharing of data.

- 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.

- Knowledge of R&D and the clinical development process

- Ability to manage multiple priorities and assist with priority setting as required

- Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc.) to audiences with varied and sometimes limited technical knowledge

- Experience working in large, diverse team environment with changing priorities

- Good understanding of R&D and the clinical development process to enable understanding of patient level data 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.

- 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 achieve timely delivery.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities :

- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.

- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

- Continuously looking for opportunities to learn, build skills and share learning.

- Sustaining energy and well-being.

- Building strong relationships and collaboration, honest and open conversations.

- Budgeting and cost-consciousness.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKilne (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

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