Principal Clinical Study Manager

1 month ago

Gurugram, India Haleon Full time

Job Purpose:

Principal Clinical Study Manager is at the heart of our Evidence Generation activities and aligned to our Cultural pillars of Go Beyond, Do What Matters Most and Keep it Human. The role provides operational leadership to the Clinical Study Team and is responsible for the planning, management, execution, and delivery of the trial according of the study to timelines, budget, and quality. The role will require a robust use of project management tools and operational practices.

Study Team Leader and primary operational contact for 1-3 trials of average design and protocol complexity, including clinical trials, behavioral testing, and decentralized/virtual trials. Has the ability and agility to manage the delivery of any types of studies (complex/ unusual study designs, new indications, challenging regional environment and local regulations) and strategically influence the operational delivery. Responsible for the implementation, conduct and tracking of study trials in compliance with ICH/GCP and local regulations, company SOPs and written standards for the conduct of human subject research, study timelines, within budget and to project specifications. Provides operational and strategic leadership to assure successful delivery of trials.

Oversight of clinical sites, CROs and vendor activities according to the Functional Service Provider (FSP) or Full-Service Outsourcing (FSO) models.

Contributes to the plans and study documents from an operational standpoint, such as protocols, informed consent forms, monitoring plans, vendor contracts, clinical study reports, etc.

Acts as HBS custodian Take on functional leadership responsibilities, providing expert consult for issue resolution, piloting new ways of working.

Key role & responsibilities:

Deliver in alignment with Haleon’s purpose, strategy, and culture. Ensures studies are conducted in compliance with ICH/GCP and local regulations, Haleon’s SOPs and other written standards.

Accountable for study and or project delivery, and therefore possesses a strong project management acumen that drives the coordination of study activities across cross functional disciplines

Accountable for the implementation, conduct and tracking of clinical trials, according to study timelines, within budget and to project specifications.

Functions as the Business Owner for all Clinical Development third-party vendors for the execution of responsible studies.

Develops study plan and forecast, including detailed schedule and budget

Develop, maintains, and drives regular review the study Risk Management Plan and contingency planning, and Study Oversight Plan and tracking.

Assures issue management and escalation according to Written Standards. Ensures appropriate follow-up actions are taken

Tracks delivery to time, cost, and quality, including maintenance of standard tools such as, Veeva Vault/CTMS, Finance Tool and MSProject

Prepares or oversees study management, monitoring and study plans

Drives After Action Reviews (AARs) and facilitates other learning activities

Miniumum Requirements:

Bachelor’s degree in Science or Health-related field preferred.

10 years of significant experience in managing clinical research studies, clinical operations or equivalent. Has a established competencies in clinical research and clinical study management, associated regulatory, processes and quality requirements. T

Track record of success in continuous improvement, innovative work practices and driving changes to achieve these.

Demonstrated team leader experience either directly and/or as a matrix organization.

Demonstrated experience representing an organization with external stakeholders, including for example, Contract Research Organizations, Investigational Sites, Healthcare Organizations and External Experts.

Demonstrated business acumen.

Excellent verbal and written communication skills in English

Matrix management experience required.

Project management/leadership experience required

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. 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.

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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.

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