Planet Pharma
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Clinical Trial Manager
role at
Planet Pharma
Pay is commiserate with experience and ranges between $115-125/hr.
Role and Responsibilities
Responsible for developing strategy and methodology of clinical operations programs.
Ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection‐ready.
Excellence in planning, oversight, and delivery of clinical programs/trials from Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area, focusing on speed and value as Medicine Excellence goals.
Oversee budgets and timelines and support implementation using local relevant local regulations and international ICH‑GCP guidelines.
Provide operational and strategic input on training materials, program‑specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
Ensure timely execution of excellence input into various documents, including asset evidence plan and clinical trial protocols.
Collaborate with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable.
Drive site selection and subject recruitment programs to deliver study enrollment targets.
Participate in database creation and user acceptance testing, provide input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
Participate in SOP development, process mapping, training of CTAs, and other departmental activities.
Partner and liaise with internal team members across the globe, including technical leads in multiple functional areas, project management, and regulatory affairs.
Minimum Education & Experience Requirements
M.S or Ph.D. in basic sciences with 10+ years’ experience in Clinical Operations at a biotechnology or pharmaceutical company or CRO.
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. Experience leading global trials outside the US/UE/Asia/Americas is preferred.
Advanced experience with patient recruitment, non‑compliance, safety, document management, investigational product, and budget management.
Demonstrated experience in successful planning and implementation of clinical trial operations.
Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
#J-18808-Ljbffr
Clinical Trial Manager
role at
Planet Pharma
Pay is commiserate with experience and ranges between $115-125/hr.
Role and Responsibilities
Responsible for developing strategy and methodology of clinical operations programs.
Ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection‐ready.
Excellence in planning, oversight, and delivery of clinical programs/trials from Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area, focusing on speed and value as Medicine Excellence goals.
Oversee budgets and timelines and support implementation using local relevant local regulations and international ICH‑GCP guidelines.
Provide operational and strategic input on training materials, program‑specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
Ensure timely execution of excellence input into various documents, including asset evidence plan and clinical trial protocols.
Collaborate with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable.
Drive site selection and subject recruitment programs to deliver study enrollment targets.
Participate in database creation and user acceptance testing, provide input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
Participate in SOP development, process mapping, training of CTAs, and other departmental activities.
Partner and liaise with internal team members across the globe, including technical leads in multiple functional areas, project management, and regulatory affairs.
Minimum Education & Experience Requirements
M.S or Ph.D. in basic sciences with 10+ years’ experience in Clinical Operations at a biotechnology or pharmaceutical company or CRO.
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. Experience leading global trials outside the US/UE/Asia/Americas is preferred.
Advanced experience with patient recruitment, non‑compliance, safety, document management, investigational product, and budget management.
Demonstrated experience in successful planning and implementation of clinical trial operations.
Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
#J-18808-Ljbffr