The incumbent must have
an associate’s degree (or equivalent) and 5-7 years of clinical
research/development experience or a bachelor’s degree (or equivalent) with 2 -
3 years of experience in clinical research/development in the pharmaceutical
Skill & Competency
- The incumbent must have the ability to manage multiple
parallel tasks; work
unsupervised, have effective computer skills,
possess the ability to
apply new techniques, and strong prioritization skills.
- Must display effective planning and organizational
and keen attention to
detail and excellent follow through.
- The incumbent must have strong interpersonal skills in
working with highly qualified
teams, 3rd parties and people
in a global environment.
- Excellent written and oral communication skills.
Pay rate: $33.00 to $36.00 per hour.
Travel Requirements: N/A
Exciting opportunity to
work for a global leader in the pharmaceutical industry. We have an immediate
opening for an experienced Clinical Trials Specialist. This incumbent must be
polished, professional and extremely reliable. Our ideal candidate will have
pharmaceutical or CRO experience.
The Clinical Trial
Specialist contributes to the organization’s drive for business quality and
efficiency by being responsible for facilitating and providing efficient study
support and expertise to the global study management teams. The CS study and
project coordination activities are accomplished because of a strong skillset,
understanding of clinical science operations and global operating processes of
drug development within the complex boundaries of an early phase study.
CS Clinical Trial
Specialist (CTS) collaborates with the OPLs, Study Managers, Study Teams,
CRO’s, and other key stake-holders for the global trial initiation conduct and
reporting of trial progress by coordinating and performing assigned development
and operational activities. The CTS is instrumental in enabling Global Clinical
Program and Study Management in achieving efficiency, compliance, quality as
well as project/study milestones in both internally managed and outsourced
complex clinical projects and trials. The CTS is expected to directly liaise
with OPL and StM (and ECL as applicable), and play an active role in
operational oversight, logistical planning, project and study status
monitoring, corrective action planning, systems support and study
communications. Provide overall operational technical support and expertise for
managing programs and studies.
These global studies are
conducted within the standards set by Global Development, according to Good
Clinical Practices (GCP) and applicable regulatory and legal requirements and
include the key operational responsibilities for CTS:
1. Maintain global
operational tracking and reporting systems and tools including but not limited
to he study/project budget and financial management data), YourDOCeS
(invoices), IMPACT (updates for planned/concept studies), ShareDoc PhlexGlobal
(eTMF documents), Quality Risk Indicator systems, eFilia (contracts), Study
drug destruction trackers etc. Develop study specific tracking systems if
2. Provide detailed
support for cost tracking (study budgets, project budgets and special events.
Exercise clear decision making on invoice reconciliations based on knowledge of
the protocol, patient visit design, lab draw timings and other study specific
parameters that require understanding of the therapeutic area specifics and
3. Provide technical and
administrative support and expertise for contract tracking by acting as a main
point of contact for contract handling and by liaising globally with internal
and external partners to facilitate progress and identify potential issues.
4. Assist with oversight
of study metrics, compliance with systems use and present/report issues,
progress, and status at global meetings via written and verbal communication
5. Assist and
collaborate in development of project / study related documents. Support
Clinical Study Report preparation (e.g. appendices) if applicable.
6. Coordinate project /
study material preparation and global study communication internally and/or
- Consistent and collaborative communication to internal
(CSM, cPharm, GCS –ECL, OPL, STM, CLM, CRA, etc.) and external partner
(CRO, Laboratory, etc.).
- Create and send communications materials to countries
and/or study sites (e.g. Newsletters, updates, etc.).
- Support the maintenance and construction of study
specific internet based forums, such as study websites, SharePoints,
Investigator Portal, etc.
- Coordinate communication of project/study status to
various levels of management
7. Provide meeting
coordination for the global clinical and study team members (StM, OPL, cPharms)
in scheduling, agenda, presentations, arrangements, minutes, and action item
tracking including global and regional investigator meetings, global/regional
monitor training meetings (if applicable) and advisory committee meetings as
requested by ECL/OPL.
8. Responsible for
setting up, maintaining on ongoing basis, providing expertise in quality controlling
and archiving of the global Trial Master File (TMF) (paper TMF or eTMF) –
including but not limited to Study Files. Provide technical knowledge of the
“essential documents" as described in the SOPs and required by the global
regulatory authorities (FDA, SFDA, PMDA, MOH EMA, etc.). Provide proactive,
close support to Study Manager with quality control and verification of the TMF
managed/maintained by external suppliers. Participate and support audits
(Regulatory Authorities and the QA), inspections and verification of TMF.
Ensure the quality, completeness, availability and quality of the clinical
study documents in the Trial Master File to enable final compilation of the
documents for regulatory submissions and approval of new medications and medical
9. Provide expertise in
- Provide technical expertise for the eTMF.
- Provide consultative guidance on new systems, processes
and procedures (e.g. SharePoint, inspection readiness, etc.)
- May represent GCP&SM Support Service in areas of
various initiatives (e.g. as representative or leader of the expert
working groups,) Actively suggest means to increase efficiency and other
- Provide technical expertise of the budget and payment
systems (YOUR-DoceS, for assistance with forecasts, actual cost updates,
etc.) Provide expertise with the use of SOP repository (QDoc and others as
- Support to functional Heads of ECL&OPLs in
presentations, organizing trips, equipment ordering, and other general