Planet Pharma
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http://www.theplanetgroup.com
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As part of this exciting journey, we need a dynamic, creative, motivated, and talented individual to join our team as Global Clinical Project Lead.
As our Global Clinical Project Lead, you will be responsible for the oversight of day-to-day operations for assigned studies within a program while working closely with all contracted vendors and key stakeholders to ensure timely study set-up and successful study completion.
In your role, you will report to the VP Clinical Operations and will also work closely with all members of the team including clinical operations, clinical science, product development, pharmacology, non-clinical, CMC, business development and beyond to advance each assigned program.
ESSENTIAL FUNCTIONS • Responsible for the oversight of day-to-day study operations for assigned projects within a program under the VP Clinical Operations, working closely with all vendors for the assigned project(s)
• End-to-end project management of the assigned clinical program, from clinical trial concept, including Protocol development, through to study set-up including source document development, case report form design and review, informed consent form design and review, investigator selection and training, and vendor selection. Study management including recruitment, safety reporting management. supply management, data collection, clinical study report compilation, and study close-out.
• Management of clinical operations study teams and investigative sites to ensure successful execution of the protocol on time, within budget and in accordance with country-specific regulations, ICH Guidelines of Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs).
• Provide project status updates, data, and reports as applicable and requested
• Assist with program-level strategy, timelines, trial design, and implementation
• Accountable for developing and managing project-level plans, timelines, and budgets
• Manage, facilitate and document cross-functional project team meetings (e.g. meeting agenda, minutes, operational risk, action items. and decision logs) to enable effective and timely decision making • Manage study team communications to ensure cross-functional connectivity among study team members and supporting functional staff
• Review, provide input and guide completion of study-related plans (i.e. project management plan, communication plan, monitoring plan, regulatory submission plans, training plans, risk mitigation plans, study close out plans, etc.)
• In partnership with other functional areas, coordinate the completion of cross-functional plans (data management, medical monitoring/safety management plan, etc.); participate in UAT of systems.
• Evaluate work processes on an ongoing basis to identify inefficiencies and gaps and provide solutions to resolve identified issues.
• Anticipate/recognize problems in advance of potential study milestone delays and lead problem-solving, risk mitigation and contingency planning at site and study team level to ensure successful completion of study according to timelines and budget in support of program objectives.
• Identify and communicate study risks, recommend, and lead the implementation of mitigation strategies in alignment with senior management.
• Appropriately escalate issues in a timely manner and ensure resolution or mitigation.
• Develops and maintains positive relationships both internal and external stakeholders.
• Lead team through clinical compliance initiatives and audits.
• Assist in the hiring and selection process for staff involved in clinical operations by participating in the interviewing process. Ensure that new employees are properly onboarded and trained.
• Coach and provide guidance to clinical operations staff.
REQUIREMENTS
• Bachelor’s Degree in a medical/science/nursing field, master’s degree desired.
• Minimum of 7 years of direct clinical project management experience in leading business critical or pivotal international clinical trials.
• Demonstrated competence in and understanding of the application of clinical research standard operating procedures, ICH GCPs, and local/global regulations.
• Team leadership skills with a proven track record of successful management of cross-functional teams involving all clinical trial activities for multi-centre domestic or international studies.
• Strong project management skills with a proven track record of applying project management expertise to ensure that clinical trials are delivered on time, within budget, and to the expected quality.
• Experience in managing studies involving countries with diverse regulatory requirements.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Excellent written and verbal communication skills, acute observational skills, analytical and conceptual capabilities.
• Competence in the use of all software common to clinical trial project management, including Microsoft office, project management applications, EDC, CTMS, RTSM, and document repository applications.
• Ability and willingness to work remotely with minimal supervision.
• Ability and willingness to travel, sometimes extensively, locally and internationally.
Target Pay Rate Range: $80-$90/hr. Salary will be commensurate with experience
Global Clinical Project Lead
REMOTE REMOTE, IL 00000 US
Posted: 03/20/2023
2023-03-20
2023-04-24
Employment Type:
Contract To Hire
Job Category: Clinical Development and Operations
Job Number: 545528
Is job remote?: Yes
Country: United States
Job Description
As part of this exciting journey, we need a dynamic, creative, motivated, and talented individual to join our team as Global Clinical Project Lead.
As our Global Clinical Project Lead, you will be responsible for the oversight of day-to-day operations for assigned studies within a program while working closely with all contracted vendors and key stakeholders to ensure timely study set-up and successful study completion.
In your role, you will report to the VP Clinical Operations and will also work closely with all members of the team including clinical operations, clinical science, product development, pharmacology, non-clinical, CMC, business development and beyond to advance each assigned program.
ESSENTIAL FUNCTIONS • Responsible for the oversight of day-to-day study operations for assigned projects within a program under the VP Clinical Operations, working closely with all vendors for the assigned project(s)
• End-to-end project management of the assigned clinical program, from clinical trial concept, including Protocol development, through to study set-up including source document development, case report form design and review, informed consent form design and review, investigator selection and training, and vendor selection. Study management including recruitment, safety reporting management. supply management, data collection, clinical study report compilation, and study close-out.
• Management of clinical operations study teams and investigative sites to ensure successful execution of the protocol on time, within budget and in accordance with country-specific regulations, ICH Guidelines of Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs).
• Provide project status updates, data, and reports as applicable and requested
• Assist with program-level strategy, timelines, trial design, and implementation
• Accountable for developing and managing project-level plans, timelines, and budgets
• Manage, facilitate and document cross-functional project team meetings (e.g. meeting agenda, minutes, operational risk, action items. and decision logs) to enable effective and timely decision making • Manage study team communications to ensure cross-functional connectivity among study team members and supporting functional staff
• Review, provide input and guide completion of study-related plans (i.e. project management plan, communication plan, monitoring plan, regulatory submission plans, training plans, risk mitigation plans, study close out plans, etc.)
• In partnership with other functional areas, coordinate the completion of cross-functional plans (data management, medical monitoring/safety management plan, etc.); participate in UAT of systems.
• Evaluate work processes on an ongoing basis to identify inefficiencies and gaps and provide solutions to resolve identified issues.
• Anticipate/recognize problems in advance of potential study milestone delays and lead problem-solving, risk mitigation and contingency planning at site and study team level to ensure successful completion of study according to timelines and budget in support of program objectives.
• Identify and communicate study risks, recommend, and lead the implementation of mitigation strategies in alignment with senior management.
• Appropriately escalate issues in a timely manner and ensure resolution or mitigation.
• Develops and maintains positive relationships both internal and external stakeholders.
• Lead team through clinical compliance initiatives and audits.
• Assist in the hiring and selection process for staff involved in clinical operations by participating in the interviewing process. Ensure that new employees are properly onboarded and trained.
• Coach and provide guidance to clinical operations staff.
REQUIREMENTS
• Bachelor’s Degree in a medical/science/nursing field, master’s degree desired.
• Minimum of 7 years of direct clinical project management experience in leading business critical or pivotal international clinical trials.
• Demonstrated competence in and understanding of the application of clinical research standard operating procedures, ICH GCPs, and local/global regulations.
• Team leadership skills with a proven track record of successful management of cross-functional teams involving all clinical trial activities for multi-centre domestic or international studies.
• Strong project management skills with a proven track record of applying project management expertise to ensure that clinical trials are delivered on time, within budget, and to the expected quality.
• Experience in managing studies involving countries with diverse regulatory requirements.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Excellent written and verbal communication skills, acute observational skills, analytical and conceptual capabilities.
• Competence in the use of all software common to clinical trial project management, including Microsoft office, project management applications, EDC, CTMS, RTSM, and document repository applications.
• Ability and willingness to work remotely with minimal supervision.
• Ability and willingness to travel, sometimes extensively, locally and internationally.
Target Pay Rate Range: $80-$90/hr. Salary will be commensurate with experience
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