Working at Horizon is more than a job it's personal. For us, success is measured by the numbers that matter most the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.
The primary responsibility of the Senior Manager is to manage the day-to-day operational activities that support Horizon sponsored clinical trials. The primary focus will be on meeting or exceeding the study-specific clinical project plans.
Facilitates and accelerates the development, execution, completion, and reporting of clinical trial(s) to meet or exceed the project plan(s) within budget and on time
Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants
Coordinates and contributes to designing, planning, development, monitoring and reporting of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant.
Primarily responsible for some or all study level deliverables including but not limited to: risk assessment, monitoring plan, study reference/procedure manual, pharmacy manual, template consent, data management plan, statistical analysis plan, safety management plan, etc.
Ensures that all staff (internal and external) assigned to a study are adequately qualified and trained and that the qualifications and training are documented and submitted to the Trial Master File
Ensures that the trial master file is prepared, maintained, and catalogued adequately. Ensures the quality control of critical documents.
Oversees or personally executes the management of clinical supplies and clinical supply vendors.
Manages or ensures the adequate management of other trial related materials and vendors, e.g. ancillary supplies, central laboratories, central IRB, etc. Assist in managing CRO's/ independent contractors under the direction of the Sr. Director.
Organizes or oversees investigator meetings and other study level meetings. Creates and delivers presentations on study topics as appropriate.
Compile and maintain project specific status reports. Communicates project status to clinical team. Alerts management to risks for subjects, data quality, timelines, budget, and regulatory compliance.
Finalizes and approves selection of trial sites and investigators. Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.
Participates in departmental planning sessions and clinical policy and process development.
Is involved with up to 2 clinical products (except in times of personnel transition) and may have up to 3 direct reports including but not limited to Clinical Managers, CRAs, Document Managers/Coordinators, or other titles relevant to executing clinical trials.
Mentors, develops, and assesses direct reports including monitoring and managing workload and assignments
Qualifications and Skills Required:
BS degree in related field, scientific background.
5+ years' experience in pharmaceutical clinical research. Clinical trial management experience required.
Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations.
Strong analytical skills
Proficient in Microsoft Office
Professional, proactive demeanor
Strong interpersonal skills
Excellent written and verbal communication skills
Horizon Core Values & Competencies:
Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.