- 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. - To direct the data management activities at the asset, project or study level in support of GSKâ€™s medicine development strategy. 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 &amp; 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: - Post Graduate Degree in Scientific Discipline - 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. - Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area. - Demonstrates the project management disciplines of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics 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 â€“ 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. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. 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. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in - gsk.com-, you should disregard the same 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

Bangalore

GSK - Manager - Clinical Data Management 

GSK - Manager - Clinical Data Management  ,Job Description for GSK - Manager - Clinical Data Management  in GSK in  Bangalore for (4-8) years of experience. Apply Now!

Job Description for GSK - Manager - Clinical Data Management  in GSK in  Bangalore for (4-8) years of experience. Apply Now!