Manager, Clinical Operations
Title:
Sr Manager Clinical Operations Location:
Nutley/Hybrid Duration:
12 Months
Job Description:
The Senior Manager, Clinical Operations leads the cross-functional study team in managing one or more international clinical studies in Oncology, from Protocol Concept to Clinical Study Reporting and Disclosure.
This is an exciting opportunity for an individual with a proven track record of leading international study teams, including internal cross-functional coordination, CRO and vendor management to join a dynamic team working to deliver high quality Oncology studies to time and budget.
The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission.
This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.
Additionally, the Senior Manager manages performance and development of assigned direct report(s).
Essential Functions 1.
Managing all aspects of study progress from start-up to close-out activities and end of study reporting 2.
Preparing detailed project plan(s) with cross-functional input for all phases of the clinical study, assuring adherence to intended timelines in order to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs , identifying risks, procuring adequate resources and implementing risk mitigation plans 3.
Coordinating interdisciplinary activities throughout the study 4.
Oversight and management of CRO and clinical vendors to ensure successful conduct of the clinical trial and to ensure data integrity and quality.
5.
Effective communication with KOLs and Investigator site staff to support study delivery 6.
Contributing to individual and team development through training initiatives and team building activities.
7.
Manages performance and development of assigned direct report(s).
Requirements Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum.
Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.
Proven track record as a clinical study manager leading international study teams, including internal cross-functional coordination and CRO and vendor management to deliver high quality Oncology studies to time and budget.
Previous pharma industry experience in Oncology, including awareness of current anti-tumour therapies is essential, and the individual should be at ease with tools such as RECIST criteria for tumour assessment and NCI Common Toxicity Criteria.
Recommended Skills Clinical Works Communication Financial Management Nursing Oncology Quality Management Estimated Salary: $20 to $28 per hour based on qualifications.
Sr Manager Clinical Operations Location:
Nutley/Hybrid Duration:
12 Months
Job Description:
The Senior Manager, Clinical Operations leads the cross-functional study team in managing one or more international clinical studies in Oncology, from Protocol Concept to Clinical Study Reporting and Disclosure.
This is an exciting opportunity for an individual with a proven track record of leading international study teams, including internal cross-functional coordination, CRO and vendor management to join a dynamic team working to deliver high quality Oncology studies to time and budget.
The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission.
This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.
Additionally, the Senior Manager manages performance and development of assigned direct report(s).
Essential Functions 1.
Managing all aspects of study progress from start-up to close-out activities and end of study reporting 2.
Preparing detailed project plan(s) with cross-functional input for all phases of the clinical study, assuring adherence to intended timelines in order to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs , identifying risks, procuring adequate resources and implementing risk mitigation plans 3.
Coordinating interdisciplinary activities throughout the study 4.
Oversight and management of CRO and clinical vendors to ensure successful conduct of the clinical trial and to ensure data integrity and quality.
5.
Effective communication with KOLs and Investigator site staff to support study delivery 6.
Contributing to individual and team development through training initiatives and team building activities.
7.
Manages performance and development of assigned direct report(s).
Requirements Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum.
Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.
Proven track record as a clinical study manager leading international study teams, including internal cross-functional coordination and CRO and vendor management to deliver high quality Oncology studies to time and budget.
Previous pharma industry experience in Oncology, including awareness of current anti-tumour therapies is essential, and the individual should be at ease with tools such as RECIST criteria for tumour assessment and NCI Common Toxicity Criteria.
Recommended Skills Clinical Works Communication Financial Management Nursing Oncology Quality Management Estimated Salary: $20 to $28 per hour based on qualifications.
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