Job description

NOTE

NOT FOR C2C

We are looking for the candidates who can work on W2 ( Pay roll )

Job Description

Responsibilities:

Project Planning: Collaborate with key stakeholders to define project scope, objectives, deliverables, and timelines. Develop comprehensive project plans, including resource allocation, budgeting, risk assessment, and mitigation strategies.

Team Management: Lead and coordinate cross-functional teams involved in clinical projects. Set clear expectations, assign tasks, and provide guidance to team members. Foster effective communication, collaboration, and motivation among team members to ensure project success.

Project Execution: Monitor project progress, track milestones, and ensure adherence to timelines and budget constraints. Identify and address any issues or bottlenecks promptly. Facilitate effective decision-making and problem-solving to keep the project on track.

Stakeholder Engagement: Establish strong relationships with internal and external stakeholders, including clinical trial sponsors, regulatory agencies, investigators, and vendors. Regularly communicate project updates, risks, and achievements to stakeholders and manage their expectations.

Quality Assurance and Compliance: Ensure compliance with applicable regulations, industry standards, and ethical guidelines throughout the project lifecycle. Implement and maintain quality management processes and documentation to support regulatory submissions and audits.

Risk Management: Identify and assess project risks and develop appropriate risk mitigation strategies. Proactively monitor and manage risks throughout the project, keeping stakeholders informed and taking necessary actions to minimize their impact.

Reporting and Documentation: Prepare regular project status reports, including key metrics, milestones, and financial updates. Maintain accurate project documentation, including protocols, study reports, regulatory submissions, and other relevant documentation as required.

Continuous Improvement: Identify areas for process improvement and contribute to the development and implementation of best practices in clinical project management. Foster a culture of learning and continuous improvement within the project team.

Requirements:

• Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or related discipline). Advanced degree or certification in project management is highly desirable.
• Proven experience as a Project Manager, specifically in clinical projects within the healthcare, pharmaceutical, or biotechnology industry.
• In-depth knowledge of clinical research processes, regulations (such as ICH-GCP), and industry standards.
• Strong project management skills, including project planning, budgeting, resource management, and risk assessment.
• Excellent leadership and team management abilities, with a track record of successfully leading cross-functional teams.
• Effective communication and interpersonal skills, with the ability to engage and influence stakeholders at various levels.
• Exceptional problem-solving and decision-making skills, with the ability to navigate complex situations and resolve conflicts.
• Detail-oriented mindset with strong organizational and time management skills.
• Proficiency in project management software and tools.
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.

Project Planning: Collaborate with key stakeholders to define project scope, objectives, deliverables, and timelines. Develop comprehensive project plans, including resource allocation, budgeting, risk assessment, and mitigation strategies.

Team Management: Lead and coordinate cross-functional teams involved in clinical projects. Set clear expectations, assign tasks, and provide guidance to team members. Foster effective communication, collaboration, and motivation among team members to ensure project success.

Project Execution: Monitor project progress, track milestones, and ensure adherence to timelines and budget constraints. Identify and address any issues or bottlenecks promptly. Facilitate effective decision-making and problem-solving to keep the project on track.

Stakeholder Engagement: Establish strong relationships with internal and external stakeholders, including clinical trial sponsors, regulatory agencies, investigators, and vendors. Regularly communicate project updates, risks, and achievements to stakeholders and manage their expectations.

Quality Assurance and Compliance: Ensure compliance with applicable regulations, industry standards, and ethical guidelines throughout the project lifecycle. Implement and maintain quality management processes and documentation to support regulatory submissions and audits.

Risk Management: Identify and assess project risks and develop appropriate risk mitigation strategies. Proactively monitor and manage risks throughout the project, keeping stakeholders informed and taking necessary actions to minimize their impact.

Reporting and Documentation: Prepare regular project status reports, including key metrics, milestones, and financial updates. Maintain accurate project documentation, including protocols, study reports, regulatory submissions, and other relevant documentation as required.

Continuous Improvement: Identify areas for process improvement and contribute to the development and implementation of best practices in clinical project management. Foster a culture of learning and continuous improvement within the project team.

Requirements:

• Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or related discipline). Advanced degree or certification in project management is highly desirable.
• Proven experience as a Project Manager, specifically in clinical projects within the healthcare, pharmaceutical, or biotechnology industry.
• In-depth knowledge of clinical research processes, regulations (such as ICH-GCP), and industry standards.
• Strong project management skills, including project planning, budgeting, resource management, and risk assessment.
• Excellent leadership and team management abilities, with a track record of successfully leading cross-functional teams.
• Effective communication and interpersonal skills, with the ability to engage and influence stakeholders at various levels.
• Exceptional problem-solving and decision-making skills, with the ability to navigate complex situations and resolve conflicts.
• Detail-oriented mindset with strong organizational and time management skills.
• Proficiency in project management software and tools.
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.

Job Types: Full-time, Contract

Pay: $53,199.20 - $130,628.49 per year

Schedule:

• 8 hour shift
• Monday to Friday

License/Certification:

• PMP (Required)

Work Location: Remote

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