Clinical Trial Manager, HP ROPU ASKAN
6 months ago
The Position
Accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the ..
The Position
- Accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level.
- Contribute to delivery of BI’s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.
- Provides leadership and direction to the R/OPU trial team for their responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx).
- Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a regional/local and global level.
- Responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation from trial preparation, trial conduct and trial closeout and reporting. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate.
Duties & Responsibilities:
Regulatory and / or Organisational Requirements:
- Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices, HTGs and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality, in accordance with BI Values and a focus on speed and patient value.
- Interfaces
Functional lead and/or project manager of local/regional trial team members and colleagues including but not limited to:
- CD&O
- Other medical functions
- Local/ regional HP functions (including patient advocacy)
- CRO and other suppliers
- Investigator and site staff
- Research networks
- Patient organizations (PO)
Job Expertise
- Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
- Experience in Therapeutic Areas relevant in BI pipeline is desirable
- Understanding of local/regional major regulations
- Familiarity with guidelines and standard of care is desirable
- Experienced in working with CROs and POs is desirable
- Ability to build and maintain strong relationships of mutual value
- Excellent influencing and communication skills
Requirements:
- Degree /education: Requires a university degree (e.g. Masters degree or comparable degree) with several years relevant experience in required area. Major focus: Biomedical Life Sciences
Required Capabilities (Skills, Experience, Competencies)
- Strong Communication Skills: Demonstrates AAI approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.
- Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.
- Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviours of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal. Executes activities with a clear aim to deliver value to patients.
- Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions.
- Coordination and Oversight: Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.
- Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.
- At least 6 years’ experience in clinical research (2 years in project management), from the Pharmaceutical/CRO Industry.
- Prefer to have experience in project management for ASKAN (ASEAN, South Korea, Australia & New Zealand) for international clinical trials in phases 2 to 3. Regional experience is a must.
- Highly developed project management and team leadership capability, ability to work independently and as part of a team.
- Excellent communication and interpersonal skills. - Structured mindset, good scientific, medical and analytical thinking.
- Highly committed to timelines AND delivery of maximum quality data
- Full and permanent awareness of ethical responsibility inherent to research involving human subjects
- Good knowledge of the Clinical Development process including the regulatory requirements
- Good English language skills (spoken and in writing)
Official account of Jobstore.
