GSK is seeking a Clinical Trial Manager to join our team! As the Clinical Trial Manager, you will be responsible for the operational planning and delivery of Phase I-IV clinical trials in the US LOC (United States). You will provide oversight and manage activities across all therapy areas (Pharma & Vaccines) to the required quality standards, GSK written standards, local regulations and ICH GCP.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Leads the local study team (US) consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the country.
- The Clinical Trial Manager collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements.
- Serves as the operational point-of-contact between the central GSK study team and within country (US LOC) study team.
- As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country.
- Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs.
- Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
- Ensures that critical study timelines related to study activities within-country are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met.
- Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
- Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level.
- Provides feedback on performance, capabilities and competencies of study members to line management.
- Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
- As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.
- As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.
- Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within the country
- As required, assists with audits/inspections of local clinical operations department and study / sites in the country.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree
- 3 or more years of industry project management experience
- Experience with end to end delivery of clinical trials
If you have the following characteristics, it would be a plus:
- 5+ years project management experience
- Advanced Degree in Life Sciences
- Strong stakeholder management experience
- Proven ability to influence and build consensus
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 to getGet Ahead Together
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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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