GSK is looking for 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.Key Responsibilities:
• 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
• 5 or more years of industry project management experience
• Experience with end to end delivery of clinical trialsPreferred Qualifications:
If you have the following characteristics, it would be a plus:
• Advanced Degree in Life Sciences
• Infectious Disease, Oncology, or Vaccines experience
• Strong stakeholder management experience
• Proven ability to influence and build consensus Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get 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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GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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