Accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables.
Leads a cross-functional team trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget and in a compliant manner.
Proactively ensure that trial deliverables and milestones are met.
Identify risks and ensure mitigation and contingencies are being initiated and followed through.
Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
Requirements
Bachelor's degree is required.
Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
Experience in and knowledge of the pharmaceutical development process.
Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV).
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
Experience of leading without authority and in multi-functional matrixed and global environments.
Excellent decision-making, analytical and strong financial management skills are essential to this position.
Experience mentoring/coaching others.
Strong project planning/management, communication and presentation skills are required.
Travel up to 15-20% of the time, defined by business needs.
Benefits
an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
vacation days
parental leave for a minimum of 12 weeks
bereavement leave
caregiver leave
volunteer leave
well-being reimbursement
programs for financial, physical and mental health.
service anniversary and recognition awards
subject to the terms of their respective plans, employees