Manager, Clinical Documentation
Manager, Clinical Documentation
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Job Description
Manager Clinical Documentation (12 month secondment/ replacement)
This role is primarily accountable for implementation of elements of the strategic plan to meet GSKs commitments and to focus the R&D organisation on consistent readily accessible inspection ready and available clinical documentation in the shape of a Trial Master File for every study.
Clinical Documentation manager plays a critical and matrix leadership role with all parts of the R&D organization that contribute documentation to the TMF and implement strategies that incorporate the many systems that hold TMF information.
Clinical Documentation manager is specifically accountable for implementing strategies that build organizational capability in a pan R&D new way of working that requires a significant shift from current practices and mindset to ensure GSK is in a strong position to deliver TMFs for all studies in a simple consistent and sustainable way fully aligned with international regulatory expectations.
Areas of focus for this secondment include supporting TMF migration planning and execution in the Business Development space (Mergers Acquisitions & Divestments) and supporting initiatives towards optimizing and enhancing the usability of Veeva COV eTMF.
Responsibilities:
Plan and execute TMF migrations and support key TMF decisions within the Business Development space (Mergers & Acquisitions and Divestments)
Lead/support projects aimed at improving Veeva COV eTMF system usability efficiency and compliance
Support other various Clinical Documentation initiatives where needed
Why You
Qualifications:
Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice regulations and Corporate & R&D policies and Standard Operating Procedures for sponsor study records
Broad knowledge of clinical documentation management and archiving technologies (e.g. Veeva eTMF Documentum SharePoint) and processes.
In depth knowledge of Trial Master File Reference Model
Able to build a project plan with guidance to deliver a technical/business solution
Proven capability in delivering and embedding new ways of working
Demonstrated ability to coordinate the work of others
Proven ability to analyze business problems/opportunities
Superior interpersonal skills including the ability to establish and maintain good working relationships with peers colleagues and management
Proven record of being customer driven
Proven ability to communicate and negotiate effectively with stakeholders at all levels across functional boundaries.
Excellent written and oral communication
Why GSK
What we offer:
Career at one of the leading global healthcare companies
Contract of employment ( 12 months replacement contract)
Attractive reward package (annual bonus & awards for outstanding performance recognition awards for additional achievements and engagement holiday benefit)
Hybrid working model (where GSK site are in Poland)
Extensive support of work life balance (flexible working solutions min. 23 days/week working form the office short Fridays option health & wellbeing activities)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible
Sports cards (Multisport)
Possibilities of development within the role and companys structure
Personalized learning approach (internal trainings mentoring access to online training platforms: Keep Growing Campus LinkedIn Learning Business Skills Harvard Manage Mentor Skillsoft and external training)
Supportive community and integration events
Modern office with creative rooms fresh fruits every day
#LIGSK
#LIHYBRID
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
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 GSKs 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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Manager
Employment Type
Full-Time
Key Skills
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