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