Your responsibilities include, but
are not limited to:
• In collaboration with Trial Statistician, support development of Reporting
and Analysis Planning (RAP) modules in line with program standards.
• Responsible to provide expert support in development of and implementation of
relevant data capture tools in collaboration with CSD, GTL and IIS as
documented in data handling plan or equivalent document (e.g. CRFs, protocol
deviations, questionnaires, diaries, translations, edit checks)
• Responsible for performing expert review of ongoing clinical trial data as
outlined in the data handling plan or equivalent, supports GTL to prepare
database lock; and performing data reconciliation along the whole trial
duration in collaboration with management.
• Collaborate with Medical Lead/BSL to identify any safety trends; and as
needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and
GPT).
• In collaboration with Medical Lead or CSD/CSAD, responsible for final
analysis and interpretation of results including the development and drafting
of clinical trial reports, publications, and internal/external presentations.
• Provide support for biomarkers planning and or execution. Lead/ participate
in global process improvement work streams or act as Subject Matter Experts for
training or SOP.
• May support CSD in program level activities where needed including
submissions. Participate in the on-boarding, mentoring and training of CSE1 and
new hires
Minimum requirements
• Advanced (masters) degree in life
sciences/healthcare (or clinically relevant degree)/ PharmD is required. PhD or
MD preferable. Fluent English (oral and written)
• >3 years’ experience in Pharmaceutical industry/ clinical research
organization
• Advanced knowledge with hands on experience in planning, executing, reporting
and publishing global clinical studies in a pharmaceutical company or contract
research organization.
• Strong interpersonal skills. Ability to work under pressure. Excellent
negotiation and conflict resolution skills. Collaborates across boundaries for
shared success
• Resolve issues with minimal/ no supervision and understands when to escalate
• Thorough knowledge and expertise in Good Clinical Practice, clinical trial
design, statistics, regulatory processes, and clinical development process.
Strong analytical / computational background
• Demonstrates excellent Medical / scientific writing skills. Demonstrates
expert knowledge and application of statistical analysis methodology and can
identify trends and analyze/ interpret/ report data effectively.
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