Vaga de ASSOCIATE MANAGER, CLINICAL OPERATIONS
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ASSOCIATE MANAGER, CLINICAL OPERATIONS-2407021177WDescriptionKenvue is currently
recruiting for:Associate Manager, Clinical Operations This position is based at
São José dos Campos, Brazil. Who We AreAt Kenvue, we realize the extraordinary
power of everyday care. Built on over a century of heritage and rooted in science,
were the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®,
LISTERINE®, JOHNSONS® and BAND-AID® that you already know and love. Science is
our passion; care is our talent. Our global team is made by 22,000 diverse and
brilliant people, passionate about insights, innovation and committed to deliver
the best products to our customers. With expertise and empathy, being a Kenvuer
means to have the power to impact life of millions of people every day. We put
people first, care fiercely, earn trust with science and solve with courage and
have brilliant opportunities waiting for you! Join us in shaping our futureand
yours.What will you doThe Associate Manager, Clinical Operations is responsible
for coordinating the study management operational aspects for Higher complexity
clinical studies for regional and/or global projects for Consumer Health products
that may include Baby, Face, Body, Sun Care and Self Care in support of product
development and claims substantiation.Clinical Operations activities include (but
are not limited to) clinical study management under GCP compliance, development,
planning, startup, conduct, and closure of clinical studies as well as site/CRO
qualification and management, technical support to Junior Study Managers.Key
Responsibilities Lead all operational aspects of assigned clinical studies in
accordance with ICH GCP guidelines, company standard operating procedures, and
local regulations.Ensure that all clinical trials are conducted in compliance with
the study protocol and all contractual agreements to ensure subject safety, data
quality and accurate study timelines, budgets and quality standards are
met.Participate in and coordinate the selection/evaluation/setup of external
service providers (ESPs) (e.g., study sites, investigators, etc.) including
execution of quality/security assessments, confidentiality agreements, healthcare
compliance submissions, clinical trial agreements, and purchase orders, in
cooperation with Healthcare Compliance, Quality & Compliance, Information Security
Risk Management, and Contracting teams.Serve as the primary point of contact with
selected ESPs and train site personnel on study-specific protocol procedures and
overall general Kenvue requirementsCollaborate under the direction of Clinical
Operations Study Management Leads globally who will provide study operational
delivery strategy and guide on critical study elements.Prepare and/or
review/approve study-specific essential documents including informed consent forms
(ICFs), training materials, source documents, case report forms (CRFs),
statistical analysis plans, recruiting materials, etc.As needed, coordinate the
translation of study-specific documents and the procurement of appropriate license
agreements.Oversee preparation and clinical release of investigational and
auxiliary products, including determining required quantities, approving clinical
label copies, overseeing development of reference safety materials, and ensuring
accountability and final disposition of the products.Ensure Sponsor oversight by
monitoring the progress of studies and the performance of ESPs on a continual
basis through review/preparation of monitoring plans/reports, ongoing
communication with the ESPs, review of clinical listings and logs, and
routing/resolution of queries.Identifies and raises study-related issues and
deviations to study team and senior management. Participates in the generation of
corrective and preventative action plansEnsure that all Adverse Events (AEs),
Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies
are reported within required reporting timelines and documented/processed
appropriately. Set-up and maintain the Trial Master File (TMF) in real time
following internal procedures.Coordinate and lead clinical trial disclosures on
public registries, as needed.Track invoices against key deliverables and
review/approve invoices from vendors to ensure timely payment and compliance with
contracts and study budgets.Write and review of Clinical Study Reports, ensuring
they are written and approved within required timelines.Provides administrative
and technical support to the junior Study ManagersProvides administrative support
for site activation activities.Aids the development of the critical path for site
activation within assigned projects in support of rapid site activations.
QualificationsWhat we are looking forRequired Qualifications Minimum of a
bachelors degree in Science, Nursing, or related field.Experience as an
independent Clinical Study Manager (or equivalent role) including, but not limited
to, experience with protocol development, informed consent form, and other
essential clinical documents and electronic trial master file (TMF)
management.In-depth knowledge of electronic trial master file (TMF) management and
clinical trial management system (CTMS)Demonstrated working knowledge of cosmetic
and drug regulations globallyAdvanced English is required (spoken and
written).Excellent written and verbal communication and presentation skills, in
English. Flexible attitude and ability to work with global study teams in an agile
environment.Excellent attention to detail.Good problem-solving and critical
thinking skills.Efficient, organized, and capable of prioritizing multiple
tasks.Proficiency in ICH GCP regulations/guidelines.Proficiency in Microsoft
applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.Good
interpersonal relationship skills and being able to work effectively in
cross-functional teams both internally and externally to the
organization.Willingness to adapt to changing priorities and assignments. Desired
Qualifications CCRP or equivalent certification.Experience as a Clinical Study
Manager in global drug clinical studies.Primary LocationLatin America-Brazil-São
Paulo-São José dos CamposJob FunctionR&D