Senior Clinical Trial Manager
Company: Sanofi
Location: Bridgewater
Posted on: June 26, 2022
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Job Description:
Our Team:EDO Mission:To provide a competitive operational
expertise in clinical development from biomarker validation and
first in Man to Proof of Concept trials.To set-up, conduct and
deliver clinical studies/databases for early phase clinical trials
while optimizing costs, timelines and quality.Job Description:The
Senior Early Development Operations (EDO) Global Study Manager
(GSM) is responsible for the overall operational planning,
management and execution of a of Early Development Operations
clinical trials (phase I studies and/or complex patients' studies)
in compliance with ICH, GCP's, SOPs, local requirements,
internal/departmental guidelines, and established timelines. The
GSM is the leader of the clinical study team and empowered to drive
the management & delivery of the study team operational objectives,
ensuring all trial deliverables are met according to the study
timelines, within budget and having the highest quality standards.
The senior GSM is responsible to coordinate EDO operational teams
including coGSM, DM, CTA.The senior GSM ensures implementation of
project/indication strategies at study level for harmonization.The
senior GSM may manage studies at the product level (if applicable).
The senior GSM may be involved in monitoring activities of his/her
own studies according to workload/need and/or manages local
monitoring or outsourced monitoring. The senior GSM may also
participate in intra or inter-department Working Groups. As
applicable, the senior GSM is an ad-hoc member of the global
Project Team (GPT) and key member of the clinical sub-team and is
accountable to provide relevant updates to all members of the
GPT.The job includes international responsibilities.Provide
management and oversight of clinical trials (which may include
complex, multiple center and multinational proof-of-concept
studies) to ensure progress according to study timelinesManage
outsourced centralized activities when applicableManage CROs, study
sitesCountry management and coordination of Clinical Study Units if
applicableManagement of outsourced activitiesMentor and train/coach
GSMs, GSMs apprentices or traineesLead/participate in department or
participate in inter-department Working Groups, if applicableOther
leadership activities:Interaction with CSO-Project Leader (study
reporting, escalations, contributing to operational strategy).Serve
as internal consultant for specific departmental activities, if
applicable.Serve as Project leader for the department or external
to the department be the referent for a specific compound and
maintain accurate documentation available for the department,
participate in Project Team meetings, if applicable.The Senior GSM
could act as EDO DPE to support and coordinate phase I activities
on late-stage compound including transversal analysis across
multiple studies on a given project.Collect, synthesize, report,
file and prepare archiving for clinical trial activitiesWork
Experience:5 years minimum in management of clinical trials,
including a strong international background.Field monitoring
experience or related experience is required.Strong English
communication skills (verbal and written) if English is a second
language.Successful prior management and/or supervisory experience
in clinical operations are required.Clinical Trials Management or
Project Management experience required (approximately 5-8
years).Recognized expertise in cross functional operations.Ability
to promptly and efficiently deal with complex and cross-functional
"business situation" (risks and opportunities) in a manner that is
very likely leading to a positive outcome.Minimum required skills:
Previous and strong experience/expertise in medicine and medical
terminology (including laboratory procedures/techniques and
biological knowledge) and GCP/ICH guidelines.Very good
understanding of R&D processes including the principals of
study design and execution; knowledge of industry standards and
practices.Outstanding capability of interacting effectively with
scientists and managers from various disciplines on an
international basis.Expert and internal consultant on assigned area
and liaise with external organizations on projectsExcellent
interpersonal and communication skills (verbal and
written).Self-motivation, flexibility, attention to detail and
organizational skills, goal oriented.Expert in building optimal
collaboration within the company and with external
partners.Excellent ability to work in a team environment.Strong
leadership abilities.Extensive project Management skills.Experience
with various computer systems/database; a willingness to learn new
systems/databases.Excellent ability to prioritize
activities.Results-driven in terms of timelines and quality.Minimum
preferred skills:Previous Phase I/early patients' studies
experience preferred.Knowledge of data management
activities.Experience with management of outsourced
activities.Experience on digital initiatives implemented in
clinical trialsTechnical skills:Education: Bachelor's
degreeLanguage Requirements: Strong English communication skills
(verbal and written) if English is a second language.Physical
Requirements: N/AAt Sanofi R&D North America, we deliver
meaningful solutions for patients. We transform science into
breakthrough, best-in-class and first-in-class medicines and
vaccines. We believe in creating a diverse and inclusive workforce
- and workplace - which brings together the collective brainpower
of over 2,000 colleagues and provides you with an exciting place to
grow and develop. We set the bar high, and we deliver. Join us and
together we will build on our trusted legacy of breakthroughs for
society.Sanofi Inc. and its U.S. affiliates are Equal Opportunity
and Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.As a healthcare company and a
vaccine manufacturer, Sanofi has an important responsibility to
protect individual and public health. All US based roles require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.According to the CDC, an individual is
considered to be "fully vaccinated" fourteen (14) days after
receiving (a) the second dose of the Moderna or Pfizer vaccine, or
(b) the single dose of the J&J vaccine. Fully vaccinated, for
new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO
START DATE. GD-SALI-SAPDNAt Sanofi diversity and inclusion is
foundational to how we operate and embedded in our Core Values. We
recognize to truly tap into the richness diversity brings we must
lead with inclusion and have a workplace where those differences
can thrive and be leveraged to empower the lives of our colleagues,
patients and customers. We respect and celebrate the diversity of
our people, their backgrounds and experiences and provide equal
opportunity for all.PDN-967128bf-eed8-4834-a2d5-d9317d467a6e
Keywords: Sanofi, Trenton , Senior Clinical Trial Manager, Healthcare , Bridgewater, New Jersey
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