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An exciting opportunity to specialise within respiratory has arisen with a global pharmaceutical company based in the South. In this role you will be responsible for all operational aspects of 1 or more clinical trial(s) (Phase II through lifecycle management) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.
Responsibilities
Ensure all operational trial deliverables are met according to timelines, budget, operational
procedures and quality standards.
Provide input and contribute to the development of protocols and related documents, in the
ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
Prepare training materials and presentations related to the planning and conduct of the trial.
Prepare clinical outsourcing specifications. Responsible for management of Contract Research
Organizations ( CROs) and ensure adherence to scope of work within timelines and budget.
Manage interactions with Global Clinical Development Operations and other relevant functions
including Drug Supply Management and local medical organizations.
Accountable for accuracy of trial information in all trial databases and tracking systems.
Support the development, management and tracking of trial budget working closely with the
Therapy Area (TA) program operations group.
Participate in the organization and logistics of various oversight and Advisory boards; attend
meetings.
Point of contact for managing/answering questions related to trial procedures and patients’
eligibility.
Write Clinical Trial Team (CTT) meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team
meetings. Participate in International Clinical Team meetings.
Contribute to program level activities (e.g., tracking of CD&MA brand-related publications,
development of clinical sections of regulatory documents like Investigators’ Brochures,
briefing books, safety updates, submission documents, responses to Health
Authorities questions).
Responsible for implementation of best practices and standards for trial management within
the TA, including sharing lessons learned.
Contribute to talent and career development of TA staff through active participation in onboarding,
training and mentoring activities. May serve as faculty member for CD&MA training
programs.
Requirements
Advanced degree or equivalent education/degree in life science/healthcare required accompanied with experience in clinical research.
or
Bachelor degree or equivalent education/degree in life
science/healthcare required if accompanied with provable experience in clinical research.
Languages: Fluent English (oral and written)
Experience:
Involvement in cross-functional, multicultural and
international clinical trial teams; demonstrated
capabilities in leading specific trial related activities like
planning, executing, reporting and publishing activities.
Excellent communication, organization and tracking
skills. Strong operational skills and demonstrated
ability to meet timelines.
Proven networking skills and ability to train colleagues.
Proven ability to work both independently or in a team
setting, including a matrix environment
Knowledge of Good Clinical Practice; thorough
knowledge of clinical trial design; understanding of the
overall drug development process.
Knowledge of principles for trial budgeting.
Basic knowledge of TA preferable.
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
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