Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Clinical Operations Lead II
500 Taylor St, Fort Worth, Tx 76102 Fort Worth, TX 76102 US
Posted: 05/30/2024
2024-05-30
2024-08-16
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 607849
Is job remote?: Yes
Country: United States
Job Description
Target Pay Rate: 73.63-85.71 **salary will be commensurate with experienceÂ
Job Description:Â
The Clinical Operations Lead is responsible for performing project management tasks at country, regional and site level in support of planning, conduct and reporting of clinical trials. This person should ensure trial conduct is efficient, with seamless execution, achievement of timelines and study deliverables with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures.
Major Responsibilities:
• Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity in support of one or more projects.
• Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required.
• Develop Protocol Monitoring Plan (PMP).
• Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements, and status of CSM activities.
• Prepare, coordinate, deliver, and track protocol specific training for CSMs and site personnel.
• Initiate Investigational Product shipment requests, resupply, and coordinate reclamation of supplies from sites for assigned trial(s).
• Create and maintain user account worksheets for provisioning all site personnel for assigned trials into required systems (e.g., EDC, IRT, training portals).
• Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation.
Competency Profile
• Customer Focus
• Action Oriented
• Collaborates
• Communicates Effectively
• Plans & Aligns
• Problem Solving
Preferred Qualifications:
•           Bachelor’s Degree in life science; medical, pharmaceutical, biology, chemistry degree preferred.
•           The ability to fluently read, write, understand and communicate in English.
•           5 years of direct experience as Clinical Operations Lead or clinical trial management experience.
•           Travel requirements: 5-10% (paid for by the client)
• Field clinical monitoring, site management (e.g., study coordinator), or clinical research experience
• Project Management experience preferred
• Excellent verbal and written communication, problem solving skills and team orientation
Major Accountabilities
Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of clinical trials within CDMA. Each Clinical Operations Lead will be assigned 2-3 clinical trials of low to medium complexity in support of one or more projects.
Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.
Ensure consistency of processes and procedures across sites and studies
Contribute operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, etc.
Develop Protocol Monitoring Plan (PMP)
Follow study metrics using all available tools, systems and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverables
Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, milestones, and status of CSM activities
Coordinate study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulations
Coordinate, prepare, deliver, and track protocol specific training for site personnel and assigned CSMs
Initiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies for sites on assigned trial(s)
Create and maintain user account worksheets for provisioning all site personnel and CTT members for assigned trials into required systems (e.g. EDC, IRT, training portals)
Actively participate on the Clinical Trial Team (CTT), building relationships and serving as liaison among trial team personnel as appropriate
Facilitate communication between CTT and sites throughout the trial
Provide progress reports to CTT and upper management routinely
Proactively identify potential/actual issues and risks, escalate to CTT and management as appropriate, and contribute to mitigation
Leads/participates in department and cross-functional process improvement initiatives to improve operational efficiencies
Achievement of project specific milestones for assigned trials as defined in overall CDMA objectives:Â
First Patient First Visit (FPFV), Last Patient First Visit (LPFV), Last Patient Last Visit (LPLV), and Database Lock (DBL)
High quality/compliance in assigned trials as defined in overall CDMA objectives
Adherence to processes and procedures
Proactive identification and mitigation of issues/risks
Competency Profile
Customer Focus
Action Oriented
Collaborates
Communicates Effectively
Plans & Aligns
Job Description:Â
The Clinical Operations Lead is responsible for performing project management tasks at country, regional and site level in support of planning, conduct and reporting of clinical trials. This person should ensure trial conduct is efficient, with seamless execution, achievement of timelines and study deliverables with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures.
Major Responsibilities:
• Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity in support of one or more projects.
• Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required.
• Develop Protocol Monitoring Plan (PMP).
• Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements, and status of CSM activities.
• Prepare, coordinate, deliver, and track protocol specific training for CSMs and site personnel.
• Initiate Investigational Product shipment requests, resupply, and coordinate reclamation of supplies from sites for assigned trial(s).
• Create and maintain user account worksheets for provisioning all site personnel for assigned trials into required systems (e.g., EDC, IRT, training portals).
• Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation.
Competency Profile
• Customer Focus
• Action Oriented
• Collaborates
• Communicates Effectively
• Plans & Aligns
• Problem Solving
Preferred Qualifications:
•           Bachelor’s Degree in life science; medical, pharmaceutical, biology, chemistry degree preferred.
•           The ability to fluently read, write, understand and communicate in English.
•           5 years of direct experience as Clinical Operations Lead or clinical trial management experience.
•           Travel requirements: 5-10% (paid for by the client)
• Field clinical monitoring, site management (e.g., study coordinator), or clinical research experience
• Project Management experience preferred
• Excellent verbal and written communication, problem solving skills and team orientation
Major Accountabilities
Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of clinical trials within CDMA. Each Clinical Operations Lead will be assigned 2-3 clinical trials of low to medium complexity in support of one or more projects.
Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.
Ensure consistency of processes and procedures across sites and studies
Contribute operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, etc.
Develop Protocol Monitoring Plan (PMP)
Follow study metrics using all available tools, systems and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverables
Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, milestones, and status of CSM activities
Coordinate study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulations
Coordinate, prepare, deliver, and track protocol specific training for site personnel and assigned CSMs
Initiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies for sites on assigned trial(s)
Create and maintain user account worksheets for provisioning all site personnel and CTT members for assigned trials into required systems (e.g. EDC, IRT, training portals)
Actively participate on the Clinical Trial Team (CTT), building relationships and serving as liaison among trial team personnel as appropriate
Facilitate communication between CTT and sites throughout the trial
Provide progress reports to CTT and upper management routinely
Proactively identify potential/actual issues and risks, escalate to CTT and management as appropriate, and contribute to mitigation
Leads/participates in department and cross-functional process improvement initiatives to improve operational efficiencies
Achievement of project specific milestones for assigned trials as defined in overall CDMA objectives:Â
First Patient First Visit (FPFV), Last Patient First Visit (LPFV), Last Patient Last Visit (LPLV), and Database Lock (DBL)
High quality/compliance in assigned trials as defined in overall CDMA objectives
Adherence to processes and procedures
Proactive identification and mitigation of issues/risks
Competency Profile
Customer Focus
Action Oriented
Collaborates
Communicates Effectively
Plans & Aligns
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