Ref #: 28643

Employment type: Permanent - Full-Time

Location: Taipei, Taiwan

Posted: 23-Apr-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 Clinical Research Associate I to work closely with our client, a leading pharmaceutical company.

- This service provides global coordination for the execution for unblinded drug management, including the general facilitation of the Independent Drug Monitoring process between the Independent Drug Monitoring Team (IDM Team) and the Clinical Trial Team.

- Ensure IDM deliverables progress according to agreed upon timelines and in support of trial milestones; providing status updates, as required. Ensure inspection readiness through compliance with company Standard Operating Procedures (SOPs), codes of Good Clinical Practice (GCP), applicable other applicable regulations and guidelines from start-up through close-out.

- Takes ownership for assigned IDM responsibilities. Advanced services are more complex and/or have a greater potential impact
on business results. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non-trial project work.

Key responsibilities
• Services rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
• Comply with relevant and on-time training requirements.
• Lead study teams in management of IDM related processes and operations; ensuring blind.
• Provide input for the development of pharmacy related materials, including forms and manuals.
• System set-up including IVRS and EDC in a supportive capacity.
• Ensure adherence to quality of the IDM process, including, translation, documentation, and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.
• Act as the main point of contact for resolution of any ad-hoc questions associated with IDM issues.
• Resolve and document urgent/critical unblinded and pharmacy-related issues and investigate trends.
• Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process.
• Provide updates to Trial Team on pharmacy-related and compliance issues in a blinded fashion.
• Take initiative to suggest and implement solutions to site-level issues.
• Oversees Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites. Primary point of contact for the IDM.
• Provide communications and necessary information to IDMs on study updates, such as protocol amendments Potential of to co-monitor IDMs.
• Review IDM monitoring visit reports (initiation, periodic & close-out) and provide feedback, as needed.
• Provide back-up and support for the IDM.
• Provide training & re-training to new IDMs and site pharmacy staff.
• Ensures IDM visits occur within window and ensure any out of window visits are tracked per process.
• Ensures IDM monitoring visit reports and issue logs are up-to-date.
• Ensure existence and accuracy of relevant IDM process documentation, communication and monitoring plans.
• Provide input in audits and/or CAPAs.
• Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries, if applicable.
• Create appropriate trial-specific IDM training materials and requirements.
• Establish and maintain excellent working relationships with internal and external stakeholders.
• Maintain Blinded TMF and perform document management activities.
• Provide feedback to and train/coach/guide junior colleagues as needed.
• Work proactively to increase global awareness of IDM processes; train and educate stakeholders.
• Comply with relevant and on-time training requirements.
• Contribute to IDM process improvement and training, as applicable.
• Lead and/or participate in special initiatives, task forces or non-trial project work, as assigned; typically, in Advanced.
• Advanced services:
o Coach and/or mentor less experienced IDMMs.
o Assigned more complex projects and/or assignments that have a greater potential impact on business results.
o Autonomy in role.
o Depth of knowledge of IDMM services.

Required experience and qualifications
• Bachelor's or University degree; or equivalent, in appropriate scientific or business discipline.
• 3-5years of relevant experience in clinical trial operations in the pharmaceutical industry or CRO.
• Advanced: 5+ of relevant experience in clinical trial operations in the pharmaceutical industry or CRO required; advanced degree.
• Experience in Project Management mandatory; knowledge of databases and/or project management systems.
• Previous work in an international environment.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Effective leadership skills and ability to manage multiple stakeholders.
• Experience and ability in coordinating teams in a virtual environment.
• Proven ability to foster team productivity and cohesiveness.
• Independent complex decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Industry systems and Microsoft applications; willingness to learn new systems.
• Monitoring experience is recommended; other relevant experience should be considered.
• Willingness to travel locally/domestically.
• Proficient in speaking and writing local country language and English.
• Effective verbal and written communication skills.
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
• Experience in developing presentations and presenting key information to stakeholders.

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.