Associate Director - Global Trial Leader
Company: Carolina Pharmaceutical Research
Location: East Brunswick
Posted on: April 10, 2021
**Associate Director - Global Trial Leader**
Kelly is currently seeking a Global Trial Leader for one of the
largest global pharmaceutical companies in the world. This person
will join our Kelly FSP (Functional Service Provider) division, a
managed solution provider and business unit of Kelly Services, Inc.
This role is full-time and is offering full benefit options. As a
Kelly FSP employee you may be eligible for Medical, Dental, Vison,
401K, and a variety of other benefits to choose from. You may also
be eligible for paid time off, including holiday, vacation, and
The Global Trial Leader provides global, regional, or complex local
management of a clinical trial (s) (or Medical Affairs data
generation activity) in a country or countries.
Services/deliverables include operational oversight of assigned
project(s) at the country level for end to end project management
including start-up, execution, close-out, analysis, and reporting.
Further, services will ensure the teams operational activities are
in line with country specific regulations and trial teams are
delivering high quality data and trial documents/records that are
compliant with the assigned clinical trial protocol, company
Standard Operating Procedures (SOPs), International Conference on
Harmonization for Good Clinical Practice (ICH-GCP), and regulatory
requirements. Partners with the Clinical Program Leader (CPL),
Clinical Operations Head (COH), Global Clinical Trial Assistant
(GCTA MAO), and other Global Trial Leaders (GTL) to ensure overall
study delivery at the country level.
+ Services rendered will adhere to applicable client SOPs, WIs,
policies, codes of Good Clinical Practice (GCP), local regulatory
+ Complies with relevant training requirements.
+ Prepares high level budget estimate in response to Request for
Service is followed by detailed budget proposal. Ensures accurate
trial budget management, updates for scope changes and
reconciliation of assigned trials for both Out of Pocket (OOP)
costs and FTE costs. Responsible for overall contract management,
including review and approval of external service provider (ESP)
contracts, change orders and ensures services are delivered per
+ Act as primary company contact for assigned trial at the country
level and ensures local/country team is tracking project progress
against planned timelines and monitors patient recruitment rate to
ensure that target enrollment will be met across the allocated
countries. This may require development of local trial specific
procedures and tools, recruitment planning, contingency and risk
management, and budget forecasting.
+ Drive study compliance by maintaining and updating trial
management systems, using study tools and management reports
available to analyze trial progress. Participates in preparation
for and conduct of Health Authority (HA) inspections and internal
Quality Assurance audits.
+ Escalates corrective and preventive actions (CAPA) to GTL and CPL
when the trial deviates from plans and communicates study progress
and issues to study management teams and business partners.
+ Contributes to site level recruitment strategy and contingency
planning and implementation in partnership with other functional
areas to achieve clinical research target and works with GCO/CRO
staff in the set up and coordination of Investigator meetings, if
+ Delivers competent vendor management at the country level to
support the study and may submit requests for vendor services and
support vendor selection. This includes reviewing and approving
site and local vendor invoices as required. As required, manages
the local study drug supply.
+ Contributes to patient understanding of protocol and patient
safety by contributing to the review of country specific informed
consent in accordance with procedural document/templates. This
includes creating, reviewing and managing site specific informed
consent forms in accordance with SOPs, other procedural documents
and applicable regulations.
+ Ensures trial subject safety in that all AEs/SAEs/PQCs are
reported within the required reporting timelines and documented, as
+ Ensures Inspection readiness by maintaining complete, accurate
and timely data and essential documents in systems utilized for
trial management (e.g., CTMS and VTMF) according to expectations
(metrics) and archiving retention requirements where
+ With focus on quality, participates in preparation for, and
conduct of, HA inspections and Internal Quality Assurance (QA)
audits. Works closely with CPL to ensure CAPA is implemented for
audits/inspections or any quality related issues or concerns.
+ Ensures accurate finance reporting and trial delivered within
budget by adhering to finance reporting deliverables and timelines.
This includes forecasting and proactive management of country/local
trial budget. If applicable, may assist in negotiation of trial
site contracts and budgets.
+ Keeps the trial in compliance with local regulatory requirements
by organizing and ensuring IEC/HA approvals, if applicable.
+ May contribute as a mentor, champion, or representative of
functional area in process initiatives, as required and if
+ If applicable, region specific deliverables will be
+ Autonomy with execution of Global, Regional, and local trial
+ Depth of knowledge with Global, Regional, and local trial
+ Process leadership.
+ Primary interfaces:
Provider Functional Manager, client Point of Contact, Clinical
Program Leader (CPL), Clinical Operations Head (COH), other Global
Trial Leaders (GTL), Global Clinical Trial Assistant (GCTA MAO),
Site Manager (SM), GD functions, GCO country teams, Country Medical
Affairs teams, Clinical Pharmacology Project Managers,
Pharmacokinetic Research Managers, Project Owners, and other client
enterprise sectors applicable for study conduct.
+ Other interfaces:
Regional Quality and Compliance Manager/Specialist, Contracts and
Grants Managers, Local Drug Safety Officer (where required),
Central Study Team, Investigators, Trial personnel including
Investigators, study coordinators, pharmacists, etc., external
vendor representatives and Ethics Committee and others, as
Education and Experience Requirements:
+ Bachelors degree or equivalent required, preferably in Life
+ 8 years of clinical research experience in the pharmaceutical
industry or CRO.
+ Experience leading global clinical studies from protocol creation
to close out and being the point to lead for running the study for
+ Strong working knowledge of ICH-GCP, company standard operating
procedures, local laws and regulations, assigned protocols and
associated protocol specific procedures.
+ Strong IT skills in appropriate software and company systems.
Willingness to travel with occasional overnight stay away from home
according to business needs.
+ Excellent decision-making and strong financial management
+ Proficient in speaking and writing the country language and
English. Good written and oral communication skills as
+ Previous line management experience is a plus, but not
+ Flexibility and ability to manage study teams in a virtual
**Why Kelly** **** **?**
Kelly Science & Clinical is your connection to premier scientific
and clinical companies looking to hire talented people just like
you. Every day, we match science professionals with dream jobs that
fit their skills and interestsits the way we think job searching
should be. Nearly 100 percent of our science recruiters have a
professional background/education in science, so we know a thing or
two about the science market and how to get you noticed.
**About Kelly** ****
At Kelly, were always thinking about whats next and advising job
seekers on new ways of working to reach their full potential. In
fact, were a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live (plus, did we mention we provide a ton of benefits ?).
Connecting great people with great companies is what we do best,
and our employment opportunities span a wide variety of workstyles,
skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a
diverse workforce, including, but not limited to, minorities,
females, individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Carolina Pharmaceutical Research, East Brunswick , Associate Director - Global Trial Leader, Executive , East Brunswick, New Jersey
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