Novotech Life Science Clinical Project Specialist Recruitment
Novotech Life Science Clinical Project Specialist Recruitment. Life Science candidates apply for a clinical project specialist vacancy. Interested and eligible applicants can check out all of the details on the same below.
About the position:
The Clinical Project Specialist (CPS) supports the day to day operations of the clinical projects, providing in-house administrative support to the project team, according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The CPS will also contribute to the Clinical Operations Support function in review and maintenance of systems, processes, tools and standards.
Identify and recommend a selection of key indications and therapeutic areas in Asia-Pacific based on the epidemiology of the disease, level of clinical activity and patient recruitment barriers as well as other orphan indications.
For selected indications, map key opinion leaders and centres of excellence for based on scientific elements such as publications and historical connections with biotechnology companies.
Degree in Life Science or related field (Pharmacy, Medical, Biology)
Required Professional Experience:
- Practical experience and/or qualifications in business administration or healthcare administration.
- At least 3 years’ experience in a Clinical Trial Assistant (CTA) role, including Senior Clinical Trial
- Assistant (SCTA) or equivalent. CRO and/or Pharmaceutical experience is essential.
Other Required skills:
- Perform responsibilities of SCTA (refer to job description;) to the highest competency levels and extensive a delegation from Project Manager (PM) and senior team members.
- Take on Lead Clinical Trial Assistant (LCTA) responsibilities on regional studies providing additional top-level support to PM/Lead Clinical Research Associate (LCRA) while coordinating the regional CTA team.
- Liaise directly with client/alliance partner counterpart with respect to assigned responsibilities.
- Provide Study Program assistance ensuring consistency in administrative processes, tracking, reporting and communication across study teams.
- Assist PM and Project Director (PD) with CTMS metrics reports analysis, producing reports, gap and trend analysis, highlighting “red flags” and following up for completion.
- Contribute to the maintenance and delivery of CTA/CRA Essentials Training Programmes and serve as trainer/mentor to CTAs & SCTAs.
- May undertake line management responsibilities of the CTA team as required to assist the
- Clinical Operations Management team.
- In collaboration with Clinical Operations Management team, assist with review and maintenance of Clinical Operations Support processes, tools and SOPs as requested.
- Participate in clinical IT key systems/applications implementation and upgrades as required.
- Provide specialist support and training to selected teams with respect to set up and implementation of a processor system e.g. Project Financial Support, CTMS or document management Admin/Super User, safety management, regulatory support.
- Understand company processes in areas relevant to a CPS. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out the CPS role.
- Participate in activities of the Clinical Operations department, including a presentation at a clinical team meetings e.g. CTA forums, attendance at company meetings and contributing to the development of clinical processes and SOPs.
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company
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