Ref #: 32968

Employment type: Permanent - Full-Time

Location: Taiwan, Home base

Posted: 13-Oct-2021


If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a "Regional Sr. Project Manager" to work closely with our client, a leading pharmaceutical company.

* The Project Manager Country Operations (PMCO) is responsible for the successful execution of study deliverables and the quality execution of protocol procedures through adherence to good clinical practices (GCP),evolving regulatory requirements, and ensuring quality and consistency of monitoring activities.

* The PMCO is accountable for coordinating rapid start up activities across assigned countries together with the CRO. The PMCO will also drive adherence to timelines and milestones of study goals as well as identifying and communicating risks to the study team.

* The PMCO will ensure that the CRO assigned, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues.

* Works with the CRO to revise study specific country plans and timelines. Accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations Ensures that the studies assigned in the country are appropriately resourced.

* The PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.

* Attendance at site visits as required together with the CRO, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Sponsor Oversight, Inspection Readiness or Engagement Visits.

Key responsibilities
Accountable For:

• Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies)
• Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO)
• Quality of monitoring oversight in the country for assigned study(ies)
• Meeting recruitment targets for assigned study(ies)
• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party)
• Negotiation of site study budgets
• Oversight of FSP and /or contingent workers on assigned study(ies)
• Review if local regulatory documentation and oversight of local regulatory activities
• Relationship management with the national coordinating investigator as applicable

Responsible For:

• Timely and accurate responses to queries from the study team
• Working with Medical Affairs to coordinate site feasibility and engagement activities
• Scheduling and leading effective country calls with local study team and/ or CRO
• Resolving ICF issues in country
• Oversight of EC submissions and facilitate resolution of queries
• Proposing potential investigator sites (HCO accountable for selection)
• Conduct training of CRAs
• Review Clinical Monitoring Documentation
• Inspection readiness activities
• Relationship management with sites
• Provide feedback to Internal and External Stakeholders as appropriate
• Develop and maintain tracking tools
• Drives quality efforts to proactively identify and manage risks to study quality

Required experience and qualifications

Essential Qualifications

• Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process
• Solid knowledge of clinical development processes
• Ability to lead, troubleshoot and influence for quality and delivery
• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
• Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
• Comprehensive and current regulatory knowledge, including GCP
• Experience conducting GCP or other training is a plus
• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods)
• Good organizational skills and ability to deal with competing priorities
• Effective communication skills (written, verbal and presentation)
• Creative thinker, curious and unafraid to ask questions
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
• Proficient with MS Office Suite (Excel, Word and PowerPoint).

Preferred Qualifications

• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
• 8+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred
• Experience in all study phases and in rare medical conditions preferred
• Previous oversight and regulatory inspection experience preferred

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.