GSK is seeking a talented individual to join us as an Enablement Clinical Support Specialist
In this role, you will lead the coordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. The Enablement Clinical Support Specialist (CSS) supports the US Enablement Department and acts as a pivotal point of contact for the Country Clinical Operations Staff. You will be responsible for overseeing Clinical Support Specialist functions, including the execution of training and implementation of systems and tools. You will also act as a mentor for less experienced CSS's on process, study, technical and behavioral competencies.
Additionally, this role interfaces with clinical site staff and you must be able to convey GSK positions and requirements to a highly educated external partner group.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Why you?Basic Qualifications:
- Accountable for embedding training strategy for CSS community including managing training documentation, assessing capabilities, delivering training, and embedding new ways of working
- Responsible for developing and organizing departmental files and tracking systems to ensure information is accessible to appropriate staff
- Responsible for gathering voice of customer feedback from CSS community and providing an overarching view of the needs of the country and all functions
- Responsible as a system local expert in eTMF and CTMS to provide end-user support and training to the CSS community
- Responsible for accuracy of study systems. Proactively identifies issues and raises them to take necessary corrective action to ensure smooth and rapid progress of studies.
- Responsible for providing oversight of operational aspects of state sanctions checks and clinical and ancillary supplies team deliverables
- May assist with clinical and ancillary supplies vendor(s), preparing and reviewing importation documentation, and logistics
- May be accountable for managing the financial operational aspects of vendor agreements, setting up purchase orders, reconciling invoices, issuing, and tracking payments
- Responsible as US Archivist to inform department of their responsibilities in following the records retention policy
- May manage departmental study related training records as departmental MyLearning training coordinator
- Act as a role model, coach, mentor for new or less experienced CSSs on processes, study, technical and behavioral competencies including resolving difficult situations.
- Accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems to effectively manage them. Is the single point of contact for local study teams for study support questions.
- Adhere to GSK written standards, processes, and ICH GCP guidelines. Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions. Participate continuously in relevant training courses to improve personal/professional skills.
- Accountable to acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities. Act as a local expert/champion or subject matter expert in a business system / process.
- Share best practices within the LOC and with colleagues in other LOCs.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in a Scientific Discipline
- 3+ years' experience in clinical research (CSS) required
- Experience in all stages of study lifecycle (start-up, recruitment and close out)
- Minimum experience of 3 years in the domain is required
- Expertise regarding the operational knowledge of clinical research, given the nature of the job and the coaching/mentoring of the role
- Experience in pharmaceutical industry or health related field
- Expertise understanding and knowledge of financial aspects related to invoicing and payments
- Experience that includes knowledge of clinical study conduct processes
- Expert written and verbal communication skills in English and local language required
- Self-motivated with ability to work, solve problems and make decisions unsupervised
- Experience in communication and organizational skills with ability to interact well with all levels of management and staff
If you have the following characteristics, it would be a plus:
- Good understanding of GSK tools and system including a proficient understanding of ICH GCP guidelines.
- Solid knowledge of GSK's written standards also required.
- Self motivated with ability to work, solve problems and make decisions unsupervised.
Our values and expectationsare 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, rigor 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.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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