management for assigned projects to ensure timely delivery, data quality and
budget within control.
Act as a study team
leader to set up team goals and lead cross-function communication to get there,
including but not limited to medical, DM, Statistician, regulatory, CMC, supply
chain, legal and finance.
Implement and drive
resource strategy for Clinical Operations to meet project deliverables and
timelines and changing workloads.
organisation of appropriate training programmes in the country, as well as the
documentation of such training.
coaching to the staff.
Be accountable in the
country for strategy related to Clinical Operations activities including but
not limited to, feasibility, allocations, recruitment enablers, trial execution
and local customer relationships related to Clinical Operations (Performs management to
but not limited to clinical study start up from any stages, budget control,
initiation, patient enrollment, protocol adherence, CRF compliance, data
quality to meet specified ethical, scientific, regulatory needs. Develop and
maintain KOL relationships).
communications and relationships with CRO partners, including but not limited
to CRC, CRA, PM or DM/Stats if applicable.
Ensure the clinical
trials conduction in compliance with ICH – GCP guidelines, local regulatory
requirements, SOPs and protocols.
of 7 years experience in clinical research and 2 years middle management
experience in related fields such as clinical operations.(Minimum 5 years of
monitoring experience in clinical research)
to degree level (biological science, pharmacy or other health related
knowledge of applicable clinical research regulatory requirements; i.e., Good
Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
and compelling communication
leadership and influencing skills across geographies and culture differences
in international CROs preferred
in written and oral English is must
ability to problem-solve.
ability to manage budgets.
independently and think widely as a leader, self-motivated, fast-learner,
willing to meet challenges and share responsibilities with partners.
We offer you an open
biotech culture, an exciting journey throughout the world of drug clinical
research and development. You can expect to work with a successful,
highly-qualified and dynamic team as you develop your individual scientific and
management skills, and entrepreneur competency. You can also look forward to a
flexible working environment, a pleasant and homelike atmosphere as well as
competitive incentive package. If you are looking for a big stage for your
profession or beyond, if you are willing to walk out of your “comfortable zone”
in your career, come and join us!