GSK is seeking to hire a Study Start-Up Project Coordinator (SSUPC)!
In this role, the SSUPC will provide administration, maintenance, and coordination of logistical aspects of country level study start-up activities . This includes the management of the following processes: site feasibility, selection, recruitment planning, training, regulatory package completion and site activation.
This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position will primarily work with the local operating company (LOC) Study Start Up Managers and Local Delivery Leads as well as the global Feasibility and Recruitment Planning Managers.
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:
- Responsible for managing country and site level feasibility including developing questionnaires, analyzing responses, executing Confidential Agreements and strategizing with local delivery leads and medical team members.
- Works with key stakeholders to establish regulatory requirements and contracts necessary for start-up.
- Maintains up to date participating center's information (including all contact details, contracts, and reports).
- Responsible for preparation, collation, review and tracking of all documentation required for approvals processes (e.g. regulatory, ethics, green light process etc.).
- Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to management on site performance metrics.
- Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up
- Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Transition oversight accountabilities to the LDL and local CSS at the end of the start-up phase
- May be responsible to oversee the clinical and ancillary supplies vendor(s), preparing and reviewing importation documentation, and logistics.
- As an active participant of clinical study teams, engage in local study meetings to obtain general knowledge about the study and be responsible for given tasks.
- 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.
- Maintain effective communication and working relationships with Investigators, other site staff, above country colleagues and other GSK staff.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in relevant Scientific field (i.e., Pharmaceutical Industry, clinical operations)
- 2 years' work experience in the clinical research field
- Expert working knowledge of the ICH and FDA guidelines and of the IRBI/IEC regulations
- Experience working with cross functional teams
- Experience working with computers and various applications (i.e., Microsoft Office) required
- Experience in written and verbal communication in English and local language required
- Experience collaborating 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:
- 2 years' work experience with investigator start-up documents and investigative sites
- Demonstrated ability to multitask and prioritize work based on own judgment
- Self-motivated with ability to work, solve problems and make decisions unsupervised
GSK is a global biopharma company with a special purpose - tounite 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's 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 toget Ahead Together
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