Clinical Operations Manager
Job DescriptionAbout the Opportunity This role will be based in Charleston.
This will be an internal sponsorship movement and we are seeking an experienced line manager from Australia or Asia The Clinical Operations Manager (COM) is a key member of our amazing management team and instrumental in providing guidance and support to a team of CRAs and also to the wider clinical department.
They empower our people to conduct clinical trials according to GCP/SOPs, regulatory requirements and Project agreements.
The COM will also lead L&D responsibilities for their department and seek out business and process improvements.
Additional responsibilities will include:
Collaborating with HR to recruit, induct/train and develop employees; Providing mentorship and technical advice to less experienced clinical staff; Performance management of line reports; Review and assist with the development and maintenance of clinical operations processes and tools; Represent Novotech at industry events; Assist with PM and RLCRA duties when required.
Minimum Qualifications &
Experience:
Previous and extensive CRO line management experience within a matrix organization Tertiary qualifications in clinical or life sciences related field (relevant experience/qualifications in similar professions may also be considered); Solid background in onsite monitoring; Previous and extensive people management, performance management and staff development experience; Solid knowledge of GCP, national and international regulations and a sound understanding of how they apply to your team; Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments.
This role will close at 2pm Pacific Time on Friday, July 7, 2023.
Novotech is proud to offer a great workplace.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
About UsNovotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including:
feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management.
Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System.
Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
About the TeamNovotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC.
Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies.
Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.
Recommended Skills Clinical Trials Clinical Works Coaching And Mentoring Leadership Maintenance Matrix Management Estimated Salary: $20 to $28 per hour based on qualifications.
This will be an internal sponsorship movement and we are seeking an experienced line manager from Australia or Asia The Clinical Operations Manager (COM) is a key member of our amazing management team and instrumental in providing guidance and support to a team of CRAs and also to the wider clinical department.
They empower our people to conduct clinical trials according to GCP/SOPs, regulatory requirements and Project agreements.
The COM will also lead L&D responsibilities for their department and seek out business and process improvements.
Additional responsibilities will include:
Collaborating with HR to recruit, induct/train and develop employees; Providing mentorship and technical advice to less experienced clinical staff; Performance management of line reports; Review and assist with the development and maintenance of clinical operations processes and tools; Represent Novotech at industry events; Assist with PM and RLCRA duties when required.
Minimum Qualifications &
Experience:
Previous and extensive CRO line management experience within a matrix organization Tertiary qualifications in clinical or life sciences related field (relevant experience/qualifications in similar professions may also be considered); Solid background in onsite monitoring; Previous and extensive people management, performance management and staff development experience; Solid knowledge of GCP, national and international regulations and a sound understanding of how they apply to your team; Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments.
This role will close at 2pm Pacific Time on Friday, July 7, 2023.
Novotech is proud to offer a great workplace.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
About UsNovotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including:
feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management.
Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System.
Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
About the TeamNovotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC.
Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies.
Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.
Recommended Skills Clinical Trials Clinical Works Coaching And Mentoring Leadership Maintenance Matrix Management Estimated Salary: $20 to $28 per hour based on qualifications.
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