GSK - Manager - Clinical Study Management (3-6 yrs)
Are you looking for an opportunity to share your knowledge of how evidence generation and research studies are conducted, reported, and published? If so, this is the role for you.
As Clinical Study Management Professional you will be responsible for supporting the end to end delivery of Evidence Generation for marketed products across the classic and established portfolio. You will also work with country study teams to manage budgets, resourcing, and be responsible for tracking funded studies.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
- Single point of accountability for data management deliverables at an assigned level (asset, project or study) within a given clinical development program.
- Expert input to protocol and other plans e.g. Protocol Deviation Management Plan, Monitoring Plan and Reporting & Analysis Plan, at the development phase of a study.
- Owner and author of Data Management Plan and accountable for the execution of this plan throughout the lifecycle of the study.
- Determines the data requirements for a clinical study, including the eCRF, laboratory and eCOA
- Development and management of study validation and integration plans, including the, dataset definition for external data sources. Lead role in the management of the data vendor deliverables and performance.
- Ensures data integrity from source through to submission, publication and archiving. Accountable for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle.
- Participates in due diligence activities and risk assessments with specific emphasis on the data management and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships.
- Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise, which can include expert input to the development, implementation and communication of control documents
- We are looking for an experience individual and if you have these skills, we would like to speak to you.
- Bachelors Degree/Post Graduate Degree in Scientific Discipline with Clinical trial experience.
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
- Understanding of the tools of the trade, such as standards
- End-to-end global medicine development experience.
- Business acumen demonstrated by understanding the implications of decisions and uses this knowledge to plan, implement and manage data management issues, projects and processes that are aligned with business needs.
- Pharma, CRO and/or ARO experience. Demonstrates expertise in the identification, evaluation and selection of key global preferred provider partnerships. Ensures final contracts meet all technical and performance requirements for the appropriate business level, (asset, project or study).
- Understanding of local regulatory environment and commercial needs at applicable country levels relevant to assigned studies and projects
- Understanding and compliance with ICH GCP, and applicable policies and SOPs.
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.
GSK India RD :
- Our goal is to be one of the world- s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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.