Sr Manager, Clinical Operations
Company: Horizon Therapeutics
Posted on: November 19, 2022
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. Responsibilities:
- Facilitates and accelerates the development, execution,
completion, and reporting of clinical trial(s) to meet or exceed
the clinical development plan (CDP) and within budget and on
- 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. Support development of
Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP).
Provide oversight of monitoring activities through review of
monitoring reports, QA-GCP audit reports and communications with
investigators, study site personnel and CRAs. Provide input into
non-project related activities and development of
- 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. Review and refine Clinical Operations
Plans/Vendor Oversight Plans
- 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. Collaborate with cross-functional area heads to
ensure proper resourcing for assigned trials. Facilitate training
to clinical study teams on protocol specific topics.
- Ensures 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 File
- Oversees or personally executes the management of clinical
supplies and clinical supply vendors. Develop outsourcing specs for
vendor requests for proposal and scope of work agreements. Manage
selection of study vendors for assigned studies. Manage the
vendor(s) throughout the life of assigned clinical trial
- 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.
Develop outsourcing specs for vendor requests for proposal and
scope of work agreements. Manage selection of study vendors for
assigned studies. Manage the vendor(s) throughout the life of
assigned clinical trial
- Organizes 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
- Provide input on investigational site selection in
collaboration with Clinical Development and vendors. 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
- Participates 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
- 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
- Mentors, develops, and assesses direct reports including
monitoring and managing workload and assignments Qualifications and
- BS degree in related field, scientific background.
- 7+ years' experience in pharmaceutical clinical research.
Clinical trial management experience required.
- Ability to travel up to 20%, may require travel outside of the
- 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
- #LI-REMOTE Horizon Core Values & Competencies: Growth
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent Accountability
- Drives Results
- Ensures Accountability
- Decision Quality Transparency
- Instills Trust #LI-Remote 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
Associated topics: cytometry, drug development, drug discovery,
histotechnologist, immunohematology, microbiological, microbiology,
nutritionist, therapy, vaccine
Keywords: Horizon Therapeutics, Waukegan , Sr Manager, Clinical Operations, Executive , Waukegan, Illinois
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