The Study Start Up Project Coordinator provides 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 primarily works 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:

• 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Associate degree
• 2 years of related experience
• Experience in the pharmaceutical industry

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor’s degree
• Experience of working with a diverse group of stakeholders from various geographic areas and disciplines
• Proven ability to co-ordinate physician and scientist development projects
• Excellent verbal and written communication skills

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 – 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.

#LI-GSK

The annual base salary for new hires in this position ranges from $84,142 to $113,839 , taking into account a number of factors including work location, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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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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