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pailingroup.com
DIRECTOR, GLOBAL CLINICAL TRIAL OPERATIONS
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Base Salary : |
$120,000.00+ based on
qualifications |
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Job Location : |
Rochester, NY |
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Candidate Citizenship / Residency Requirement : |
US Citizen |
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New Position : |
Yes |
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Employment Type : |
Full Time
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No. of Openings : |
1 |
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Experience Required : |
5 - 10 years
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Degree Required : |
4 Year Degree
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Travel Required : |
to 25%
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Job Description : |
Responsibilities
· The DIRECTOR, GLOBAL CLINICAL TRIAL OPERATIONS at is
responsible for the clinical trial operations of products in the
Vision Care (contact lens and lens solutions),
Surgical/Refractive and Pharmaceutical (Rx, OTC, Generics and
Nutraceuticals) categories
· Leads a group of clinical study managers, clinical research
associates and medical writers responsible for all aspects of
clinical trial conduct and reporting.
· Accountable for product global clinical development programs
that are of high quality but also lead to timely and
cost-effective regulatory approval
· Collaborates with cross-functional teams including project
managers, preclinical, regulatory, clinical trial materials etc.
· Accountable for resource forecasting and allocation within the
Global Clinical Trial Operations group. Responsible for
proactively generating and maintaining tools to permit optimal
resource allocation aligned with project needs and category
priorities
· Responsible for optimal selection, implementation and
utilization of clinical trial management systems and processes
· Responsible for managing the selection of vendors in
accordance to company’s policies and optimal delivery of results
· Collaborates with the Clinical Quality group to ensure all
clinical trials and related activities/documents are audit
ready.
· Provides strategic input on issues related to clinical trial
timelines and feasibility
· Proactively evaluates and contributes to process improvement
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Candidate Must Have : |
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· Minimum of
Bachelor’s degree or equivalent in areas related to life
sciences, or drug development
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· At least 5
years of total experience in clinical trial management
and/or drug/device development
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· Strong
demonstrated understanding of GCP, ICH, and regulatory
compliance
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· Knowledge of
scientific methods, research design, and medical practices
and procedures in ophthalmology desirable
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Additional Information : |
Capabilities
· Demonstrated ability to work independently, initiative and
strong work ethic
· Excellent planning and organizational skills
· Strong leadership experience and motivational skills
· Ability to influence internal and external stakeholders
· Excellent oral/written/presentation communications
· Ability to work on a matrixed and cross-functional environment
· Strong interpersonal skills
· Willing and able to travel
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We Will Sponsor/Transfer H-1B and/or H-2B Candidates : |
No |
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Bonus/ Benefits : |
Will update with more
information upon request or upon selection of position. Thanks.
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Other Details : |
Industry : Healthcare
Department : Research & Development
Relocation : YES
Specific Relocation Details :
Will update with more information upon request or upon
selection of position. Thanks.
Housing Allowance : NO
Qualified candidates
please forward professional resumes along with a cover letter outlining
salary history, geographic preferences and availability in complete
confidence to:
Frank Sinclaire
- Health Care Division Group
Manager
fsinclaire@pailingroup.com
Pailin Group Professional Search Consultants
Retained Executive Search Consultants Nationwide
info@pailingroup.com
Contact A
Consultant
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