CORXEL Pharmaceuticals
SM-AD, Clinical Project Management (GLP-1)
CORXEL Pharmaceuticals, Trenton, New Jersey, United States
SM-AD, Clinical Project Management (GLP-1)
We are seeking a mature Clinical Project Lead who oversees and manages clinical trials on a global study of GLP-1. This position plays a crucial role in the development of new projects, ensuring that clinical trials are conducted efficiently, ethically, and within regulatory guidelines to bring important operations progression and results.
About the Role This position plays a crucial role in the development of GLP-1 new global study, ensuring that clinical trials are conducted efficiently, ethically, and within regulatory guidelines to bring important operations progression and results.
Responsibilities
Develop detailed project plans, timelines, and budgets for clinical trials.
Ensure that clinical trials are conducted according to regulatory requirements and organizational standards.
Coordinate with various internal and external stakeholders, including clinical research organizations (CROs), investigators, and vendors.
Oversee relationships with external vendors, including CROs, labs, and suppliers.
Lead a project team of clinical research professionals, including Clinical Research Associates (CRAs), data managers, and other support staff.
Provide guidance, training, and support to team members.
Ensure effective communication and collaboration across all functional areas of the trial.
Ensure that contracts, timelines, and deliverables are met within budget constraints.
Ensure compliance with global regulatory standards, such as GCP, ICH guidelines, and local regulations.
Manage the preparation of regulatory submissions and documentation required for clinical trials.
Proactively identify risks and issues related to the clinical trial and develop strategies to mitigate them.
Address any challenges in a timely and effective manner, ensuring the trial stays on track.
Monitor and ensure the accuracy and integrity of clinical trial data.
Ensure that clinical trials adhere to quality assurance protocols and that data is collected, managed, and reported according to industry standards.
Work with international teams across multiple time zones and countries to ensure successful global trial execution.
Adapt strategies to meet the challenges and requirements of different regions or countries.
Qualifications
Educational Background:
A degree in life sciences, medicine, pharmacy, or a related field is typically required. A master’s degree or higher (e.g., in clinical research or project management) is often preferred.
Experience:
At least 5-8 years of experience in clinical project management, including experience managing global clinical trials; strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements in multiple countries.
Project Management Skills:
Strong organizational and multitasking skills to manage complex projects and ensure timelines are met. Certification in project management (e.g., PMP) is a plus.
Leadership and Communication Skills:
Ability to lead teams, collaborate with cross-functional stakeholders, and communicate effectively with both internal and external parties; experience in conflict resolution and team management.
Cultural Awareness and Flexibility:
Given the global nature of the role, the ability to work with teams from different cultures and time zones is essential; flexibility and adaptability to handle regional challenges and differences.
Problem Solving and Decision Making:
Strong analytical skills to identify problems, assess risks, and develop effective solutions to ensure the trial’s success.
Seniority Level Mid‑Senior level
Employment Type Full-time
Job Function Research
Industries Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
About the Role This position plays a crucial role in the development of GLP-1 new global study, ensuring that clinical trials are conducted efficiently, ethically, and within regulatory guidelines to bring important operations progression and results.
Responsibilities
Develop detailed project plans, timelines, and budgets for clinical trials.
Ensure that clinical trials are conducted according to regulatory requirements and organizational standards.
Coordinate with various internal and external stakeholders, including clinical research organizations (CROs), investigators, and vendors.
Oversee relationships with external vendors, including CROs, labs, and suppliers.
Lead a project team of clinical research professionals, including Clinical Research Associates (CRAs), data managers, and other support staff.
Provide guidance, training, and support to team members.
Ensure effective communication and collaboration across all functional areas of the trial.
Ensure that contracts, timelines, and deliverables are met within budget constraints.
Ensure compliance with global regulatory standards, such as GCP, ICH guidelines, and local regulations.
Manage the preparation of regulatory submissions and documentation required for clinical trials.
Proactively identify risks and issues related to the clinical trial and develop strategies to mitigate them.
Address any challenges in a timely and effective manner, ensuring the trial stays on track.
Monitor and ensure the accuracy and integrity of clinical trial data.
Ensure that clinical trials adhere to quality assurance protocols and that data is collected, managed, and reported according to industry standards.
Work with international teams across multiple time zones and countries to ensure successful global trial execution.
Adapt strategies to meet the challenges and requirements of different regions or countries.
Qualifications
Educational Background:
A degree in life sciences, medicine, pharmacy, or a related field is typically required. A master’s degree or higher (e.g., in clinical research or project management) is often preferred.
Experience:
At least 5-8 years of experience in clinical project management, including experience managing global clinical trials; strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements in multiple countries.
Project Management Skills:
Strong organizational and multitasking skills to manage complex projects and ensure timelines are met. Certification in project management (e.g., PMP) is a plus.
Leadership and Communication Skills:
Ability to lead teams, collaborate with cross-functional stakeholders, and communicate effectively with both internal and external parties; experience in conflict resolution and team management.
Cultural Awareness and Flexibility:
Given the global nature of the role, the ability to work with teams from different cultures and time zones is essential; flexibility and adaptability to handle regional challenges and differences.
Problem Solving and Decision Making:
Strong analytical skills to identify problems, assess risks, and develop effective solutions to ensure the trial’s success.
Seniority Level Mid‑Senior level
Employment Type Full-time
Job Function Research
Industries Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr