Descripción de la oferta
About The RoleWe are looking for an experienced Clinical Team Lead to drive the successful delivery of clinical studies, support and mentor clinical operations team members, and ensure the integrity, quality and compliance of clinical trial activities from start‑up through to close‑out.Job ResponsibilitiesParticipate in all aspects of a clinical trial from development and planning to study closure.Demonstrate the ability to lead in a team environment and mentor CRAs.Execute the Clinical Monitoring Plan (CMP) in consultation with the project team and the client.Comply with applicable regulations, ICH/GCP and Evestia Clinical and/or sponsor SOPs to assess the safety and efficacy of investigational products (drugs, biologics or medical devices).Ensure that assigned sites are in compliance with the study protocol, metrics, and will within project teams under supervision, reporting to a project manager.Responsible for ongoing analysis of enrolment activities/trends and escalation/mitigation to PM/Sponsor as appropriate. Works with PM to develop strategic and tactical plans for ensuring enrolment targets are met.Oversee clinical portion of the Trial Master File (TMF) and conduct periodic review for completeness.Conduct internal team calls and Sponsor calls (as needed).Perform site qualification, initiation, interim monitoring, and close‑out visits ensuring regulatory and protocol compliance; any visits may beperformed on‑site or remotely.Must be an effective liaison between sponsors, investigators and Evestia Clinical.May travel for client meetings, investigator meetings, co‑monitoring visits, quality oversight visits, and perform other tasks based on business needs.QualificationsUndergraduate degree or equivalent combination of education, training and experience.Significant experience in clinical research and on‑site monitoring, with the expertise to lead clinical activities, support study delivery and mentor team members.Exemplary clinical monitoring, decision‑making skills and sound judgment.Current and working knowledge of applicable regulations, ICH/GCP and applicable SOPs.Thorough understanding of medical terminology and human physiology (ability to review and learn indications as background for each clinical study).Excellent information technology (e.G. computer proficiency), oral/presentation and written communication skills.Strong interpersonal skills: ability to establish and maintain strong and harmonious relationships with both internal and external customers.Excellent written and spoken English, with the ability to communicate professionally with clients and colleagues.Ability to prioritize tasks efficiently and resolve problems within set timelines.Excellent client and customer service skills.Strong organizational skills and attention to detail.Demonstrated flexibility and adaptability.Proactively identifies process improvement opportunities and develops task efficiencies.Ability to travel nationally and internationally as required.What We OfferWe believe that to do your best work, you need the best support. Our comprehensive benefits package is carefully designed to align with our culture and values, ensuring it maximizes your positive experience working here.Our Commitment to Inclusion and DiversityWe actively seek out and hire individuals with diverse backgrounds, voices, beliefs and perspectives to join our growing global workforce. We celebrate individuality and believe that diverse viewpoints fuel innovation and drive excellence. Our managers uphold an inclusive environment in all aspects of employment.Equal Opportunity & AccessibilityEvestia Clinical is an equal opportunity employer committed to diversity in the workplace. We ensure fair treatment of all applicants and employees, without discrimination based on race, color, creed, religion, national origin, age, sex, gender identity or expression, sexual orientation, disability, veteran status or any other characteristic protected by applicable law. We are committed to providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying and require an accommodation or special assistance during the application process, please notify our recruitment team by sending an email with your request to hr@evestiaclinical.com.#J-18808-Ljbffr
