Study Startup Project Coordinator

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.

Key Responsibilities:

• 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:

• Bachelor’s degree with 2 + years' experience within the Pharmaceutical Industry and clinical operations.

• Experience in study management process of research studies

• Experience of working on projects delivering to high quality and tight timelines.

Preferred Qualifications:

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

• Some project management experience

• Knowledge or experience with Veeva systems

• Knowledge of internal/external standards and policies

• Good written and verbal communication skills

• Ability to address obstacles and issues with a constructive solution orientated approach

• Advanced level of MS Office (PowerPoint, Excel, Word & Outlook)

• Excellent engagement skills

• Ability to work independently

#LI-GSK

The annual base salary for new hires in this position ranges from $93,000 to $155,000 taking into account a number of factors including work location within the US market, 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 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, 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 to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

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.

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 GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/