Clinical Development Associate - LifeArc
As part of the Clinical Development Team, the Clinical Development Associate contributes to ensuring the smooth running of Clinical Development activities, engages with new and existing networks to identify sources of clinical samples and build relationships with key opinion leaders and other stakeholders. They work in collaboration with the Assay Development Teams to execute feasibility, full product development and clinical evaluation studies for new and modified in vitro diagnostic products according to established policies, procedures, regulations, and Good Clinical Practice (GCP).
This role demands a high level of accuracy with meticulous attention to detail. Candidates will already have established a high degree of competence in clinical research studies and have a working knowledge of molecular techniques such as qPCR and NGS. They will thrive in a dynamic, multifunctional and continually evolving role and work independently with a significant degree of autonomy to carry out requisite tasks. International travel to visit collaborators/partners/clinical sites and to co-ordinate clinical studies/trials is an absolute requirement of the role.
- Participate as an active member of a multi-disciplinary team to implement, evolve and support clinical development strategies and performance/clinical evaluations for diagnostic development projects. Identify and communicate potential risks associated with strategy scenarios and forecast timescales and costs.
- Identify and liaise with new and existing clinical sample resources to source, select and procure relevant clinical samples for diagnostics development projects. Provide support in maintaining, inspecting and reporting of clinical sample records.
- Develop SOPs and other relevant documentation to ensure consistent ways of working and adherence to regulatory requirements within diagnostics development projects.
- Develop subject matter expertise on areas specific to development projects through literature review, conference attendance, training, leveraging relationships with external parties and clinical trial data review. Share insights with development teams.
- Prepare and present project progress reports to keep management and team informed.
- Proactively establish, build and maintain networks of relevant key opinion leaders and stakeholders.
- Acquire a thorough understanding of the principles of the assay and instrumentation; an in-depth "hands-on" knowledge and skills in performing assigned assays or operating instruments would be developed through training, as required.
- Develop, write and maintain clinical trial/study protocols and documentation.
- Identify and on-board clinical sites.
- Administer protocol and related study training to clinical sites, as required.
- Provide support to establish and maintain regular lines of communication with clinical study sites to manage ongoing project expectations and issues.
- Collaborate to ensure clinical studies are conducted in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements.
- Provide support to guarantee the adequacy, reliability and quality of the data collected from clinical study sites and participate in quality assurance/control processes.
- Assist in the submission of applications to independent Ethics Committees (central and local) and to Competent/Regulatory Authorities.
- Provide support to and participate in clinical study site qualification (pre-study), initiation, monitoring and close out visits. Travel to international clinical sites is requisite.
- Maintain study documentation in the appropriate Project File.
- Anticipate, identify and proactively respond to issues, problems, or opportunities as it relates to clinical development activities.
- Provide administrative support required for smooth running of Clinical Development activities.
- Perform clinical development duties that arise ad hoc, as required.
- A background/degree in Biomedical Sciences/Biology or other relevant Life Science. Industry experience is highly desirable, as is experience of working in a clinical or ISO accredited laboratory environment.
- Experience in Regulatory Affairs, particularly with respect to IVDD/IVDR legislation is highly desirable.
- Conversant with the principles of ICH GCP, SOPs, regulatory requirements and legislation governing the conduct of clinical evaluation studies for in vitro diagnostics.
- Knowledge and/or experience of working to GCP in clinical research projects.
- Experience of clinical sample/tissue procurement and thorough understanding of associated ethics principles and procedures.
- Exceptional verbal and written communication, collaboration and influencing skills.
- Ability to multitask, prioritize tasks and maintain self-motivation when managing a dynamic workload.
- Exceptional interpersonal skills with the ability to work autonomously with limited supervision, within a multi-disciplinary team, as well as with external partners and regulators.
- Ability to travel internationally as/when required.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.