Senior Manager, Clinical Trials
Company: Bausch Health
Location: Bridgewater
Posted on: May 8, 2024
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Job Description:
Bausch Health is a global company that develops, manufactures,
and markets a differentiated product portfolio across multiple
high-growth therapeutic areas including Gastroenterology, Generics,
Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. -
We are delivering on our commitments as we build an innovative
company dedicated to advancing global health. - Each day, Bausch
Health products are used by over 150 million people around the
world.Our approximately 7,000 employees are united around our
mission of improving people's lives with our health care
products.Responsibilities -Leads or collaborates on required tasks
prior to commencement of senior clinical trials that include, but
are not limited to: clinical planning, protocol development, case
report form (CRF) development, IRB submissions, investigator
agreements, informed consent form (ICF) development, site selection
and communication with senior---clinical trial sites regarding all
logistics including contract agreements, support materials and
training -Provides clinical oversight and management for
senior---clinical trials to facilitate compliance with FDA and
other applicable international regulatory requirements and company
standard operating procedures (SOPs) during all company clinical
investigations and post-market studies -Communicates with vendors
and---senior---clinical trial sites regarding study conduct, data
monitoring, logistical management of follow-up and close out study
visits to ensure compliance with protocols and GCP requirements
-Collaborates on clinical data processing in accordance with
departmental SOPs and guidelines -Verifies, reviews and tracks CRFs
and generates Data Clarification Forms (DCFs) for all missing or
inaccurate data; ensure that data changes are properly implemented
and captured in the database or data system -Assists in the
evaluation and analysis of senior---clinical trial data to
facilitate completion of senior---clinical trial reporting
requirements, including report writing, clinical
photo-documentation, FDA and manuscript submissions -Assists in
tracking study specific payments -Provides operational or workflow
support to assure that departmental and cross functional systems
and procedures are efficiently and correctly completed
-Collaborates on project teams, primarily with Clinical Operations,
Research and Development, Safety, Senior---Clinical Trial
Materials, Marketing, Regulatory and Quality/Compliance -Leads or
collaborates on technical writing projects which include white
papers, abstracts, manuscripts, and literature reviews -Liaison
between internal and external stakeholders to facilitate
cooperation of others -Conducts presentations of clinical
information concerning specific projects -Works on projects of
moderate-to-high degree of difficulty in which analysis of
situation or data requires review of identifiable clinical factors
and in which scientific and clinical perspectives should be
incorporated -Qualifications -Bachelor's degree in a health
profession or science. Advanced degree preferred. -At least 5 years
of on-going---senior clinical trials experience in the
pharmaceutical or device industry.--- Both are preferred.
-Demonstrated proficiency in knowledge of GCPs and knowledge of FDA
regulatory requirements. -Knowledge of medical terminology.
-Ability to effectively work independently -Excellent verbal and
written communication skills plus computer proficiency (Word,
Excel, Outlook) and data management experience. -10%-30% travel
required. -Language and Verbal Skills: -Individual must have good
verbal skills and written skills plus a demonstrated ability to
communicate clearly and professionally. -Analytical and Reading
Skills: -Ability to read, analyze, interpret and assist in the
creation and refinement of company procedures. Ability to identify
problems, collect data, draw valid conclusions, and report on
findings. Ability to assist in analysis of senior clinical trial
data. Ability to interpret articles published in medical and
scientific journals relative to projects and activities in Clinical
Programs. Responsible for ensuring accuracy of medical and
scientific information. -Physical Requirements: -While performing
the duties of this job the employee may be required to perform
tasks involving lifting weights of up to 30 pounds for short
durations. Duties of this job may involve standing and/or walking
for extended periods of time. Duties also involve daily keyboard
data entry. Specific vision abilities required by this job include
close vision. Duties will also include air travel both domestically
and internationally. -As required by law, -Bausch Health provides a
reasonable range of compensation for roles that may be hired in the
US. Actual compensation is influenced by many factors including
skill set, level of experience, and specific office location. For
this role, the range of starting pay for this role is -$130k -
$175k.Benefits package includes a Comprehensive Medical (includes
Prescription Drug), Dental, Vision, Health Savings Account with
company contribution, Flexible Spending Accounts, 401(k) matching,
discretionary time off, paid sick time, tuition reimbursement,
parental leave, short-term disability, long-term disability, life
insurance, accidental death & dismemberment insurance, paid
holidays, Employee Assistance Plan, commuter benefit, recognition
awards, voluntary benefits (including Identity Theft, Student Loan
and Breast Milk Shipping), employee referral bonuses and employee
discounts.#LI-remoteThis position may be available in the following
location(s): US - RemoteBausch Health Companies Inc. is an Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment regardless of race, color, religion,
gender, national origin, age, sexual orientation, gender identity
or expression, marital or veteran status, disability, or any other
legally protected status. We are committed to building diverse
teams, representative of the patients and communities we serve, and
we strive to create an inclusive workplace that cultivates
collaboration.If a candidate needs a reasonable
accommodation/adjustment due to physical or mental health
impairment for any part of the application process, they are
encouraged to send their request to humanresources@bauschhealth.com
-or call 908-927-1400 and let us know the nature of the request and
their contact information. Please be sure to include the job
requisition number.Job Applicants should be aware of job offer
scams perpetrated through the use of the Internet and social media
platforms.To learn more please read -Bausch Health's Job Offer
Fraud Statement.
Keywords: Bausch Health, New Brunswick , Senior Manager, Clinical Trials, Healthcare , Bridgewater, New Jersey
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