Manager, Clinical Operations

Company: Horizon Therapeutics
Location: Germantown
Posted on: March 20, 2023

Job Description:

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. Position Summary The Manager, Clinical Operations will perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases and aspects of the trial. The Manager will support the company's vision of a high-touch organization with their trial sites and contract research organizations. ResponsibilitiesManages clinical trials from Ph1 to Ph4 as required by Horizon development needsMay have single or multiple trial responsibility depending on pipeline needs and development stageSupports Operational Leader in delivery of trials for a molecule development planSupport development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP)Drives the development, execution, completion, and reporting of clinical trial(s) to meet or exceed the clinical development plan (CDP) and within budget and on time. Builds recruitment model and recruitment plan for a given trial, in partnership with CRO. Drives recruitment efforts internally and externallyDrives investigational site selection in collaboration with Clinical Development and vendors. Finalizes and approves selection of trial sites and investigatorsOversees directly or through team the vendors required to deliver a successful clinical trial. Develop outsourcing specs for vendors in collaboration with internal colleagues. Manage selection of study vendors for assigned studies. Manage the vendor(s) throughout the life of assigned clinical trialResponsible for study deliverables including but not limited to: risk assessment, monitoring plan, study reference/procedure manual, pharmacy manual, template consent, and refine Clinical Operations Plans/Vendor Oversight PlansProvide oversight of monitoring activities through review of data, risk-based methods where available, patient profiles, monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs. Escalates and communicates issues per SOP and with clear communication skillsEnsures 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. Facilitate training to clinical study teams on protocol specific topicsEnsures that the trial master file is prepared, maintained, and catalogued adequately. Ensures the quality control of critical documents. Oversee the submission of trial-related and essential documents to the Trial Master FileOrganizes or oversees investigator meetings and other study level meetings Creates and delivers presentations on study topics as appropriate. Participate in planning and conduct of investigator meetings and ad boards, etc.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. Lead ongoing review of data to ensure quality and consistency. Develops and manage program budget(s) and oversees site agreement/budget negotiation process and manage program timelines. Identify and provide solutions to clinical trial issues or risksEnsures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sourcesParticipates in departmental planning sessions and clinical policy and process development. Lead/oversee cross-functional CTTs for early phase studies. Define and manage accountabilities for all CTT membersCoordinates 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 relevantMay mentor other clinical operations team members that are assigned to their clinical trial(s) and may have direct reports, as delegatedQualifications and Skills RequiredBS degree in related field, scientific background.5+ years' experience in pharmaceutical clinical research. Some clinical trial management experience preferred. Prefer global clinical trial experienceExperience as an unblinded monitor or study manager is a plus.Ability to travel up to 20%, may require travel outside of the USThorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations.Strong analytical skillsProficient in Microsoft Office.Professional, proactive demeanor.Strong interpersonal skills.Excellent written and verbal communication skills.#LI-REMOTE Our Values Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleOur ValuesTransparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleCompensation and Benefits Summary:The salary range for this role is $126,000.00-$154,000.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications.In addition to the salary, this position is eligible for the benefits listed here and for the following plans:Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate BonusAt Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Germantown , Manager, Clinical Operations, Healthcare , Germantown, Maryland