The Clinical Operations Program Manager (COPM) is responsible for providing operational support for clinical development programs and trials. Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. This role will be based in Dublin, Ireland in a hybrid working approach.
About the Role
Are you ready to become a Clinical Operations Manager? The successful incumbent will be responsible for providing operational support for clinical development programs and trials. You will assist in the analysis of external and internal data to validate and refine strategic allocation of assigned trials, aligned with program allocation strategy, thereby enabling accurate overall decision making. You will partner with the Clinical Operations Project Director and will be a supporting member of the GCO sub-team ensuring delivery of the Operational Execution Plan (OEP) by applying agile and product-oriented ways of working.
Major accountabilities but not limited to: Supports the COP(a)D or the GCO sub-team to conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials. Coordinate and manage the editing, technical support resolution and distribution of information gathering questionnaire for feasibility at trial level between sites, countries and global. Ensure feedback from feasibility assessment is addressed. Partners closely with the country feasibility team to align on the end-to-end quality of feasibility product. May contribute to the Operational Execution Plan. Collection and analysis of internal and external data (i.e. local treatment standard of care, available treatment options approved/reimbursed, local prevalence and access to targeted populations) through analysis of clinical intelligence data describing the indication landscape including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally. Elaborates scenarios of geographic country footprint and proposed sites for participation in a clinical trial and supports COP(a)D, COPH a GCO sub-team on final site allocation. Contributes to the execution of the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the GCO sub-team. Contributes to the development of risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation. Supports the creation and maintenance of patient enrolment forecast, at study levels.
Key performance indicators: Timely, efficient, and quality execution of activities in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans.
Your Experience:
Degree in Life Sciences or related scientific discipline. More than 3 years of pharmaceutical clinical drug development experience is recommended. Understanding of all aspects of clinical drug development with particular emphasis on clinical trial design and trial execution. Possess resourceful research skills to locate unusual information and have capacity to develop a domain specific knowledge base. Demonstrated ability to collaborate in a matrix environment. Demonstrated experience in feasibility for global clinical trials. Communicates effectively with colleagues in a local/regional/global matrixed environment. Good project management capabilities with demonstrated ability to problem solve and mediate issues. Ability to understand analytical data insights with proven ability to communicate background details and rationale. Strong skills in MS Office Suite.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
#J-18808-Ljbffr
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. This role will be based in Dublin, Ireland in a hybrid working approach.
About the Role
Are you ready to become a Clinical Operations Manager? The successful incumbent will be responsible for providing operational support for clinical development programs and trials. You will assist in the analysis of external and internal data to validate and refine strategic allocation of assigned trials, aligned with program allocation strategy, thereby enabling accurate overall decision making. You will partner with the Clinical Operations Project Director and will be a supporting member of the GCO sub-team ensuring delivery of the Operational Execution Plan (OEP) by applying agile and product-oriented ways of working.
Major accountabilities but not limited to: Supports the COP(a)D or the GCO sub-team to conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials. Coordinate and manage the editing, technical support resolution and distribution of information gathering questionnaire for feasibility at trial level between sites, countries and global. Ensure feedback from feasibility assessment is addressed. Partners closely with the country feasibility team to align on the end-to-end quality of feasibility product. May contribute to the Operational Execution Plan. Collection and analysis of internal and external data (i.e. local treatment standard of care, available treatment options approved/reimbursed, local prevalence and access to targeted populations) through analysis of clinical intelligence data describing the indication landscape including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally. Elaborates scenarios of geographic country footprint and proposed sites for participation in a clinical trial and supports COP(a)D, COPH a GCO sub-team on final site allocation. Contributes to the execution of the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the GCO sub-team. Contributes to the development of risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation. Supports the creation and maintenance of patient enrolment forecast, at study levels.
Key performance indicators: Timely, efficient, and quality execution of activities in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans.
Your Experience:
Degree in Life Sciences or related scientific discipline. More than 3 years of pharmaceutical clinical drug development experience is recommended. Understanding of all aspects of clinical drug development with particular emphasis on clinical trial design and trial execution. Possess resourceful research skills to locate unusual information and have capacity to develop a domain specific knowledge base. Demonstrated ability to collaborate in a matrix environment. Demonstrated experience in feasibility for global clinical trials. Communicates effectively with colleagues in a local/regional/global matrixed environment. Good project management capabilities with demonstrated ability to problem solve and mediate issues. Ability to understand analytical data insights with proven ability to communicate background details and rationale. Strong skills in MS Office Suite.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
#J-18808-Ljbffr
