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Clinical Systems Manager, Clinical Business Operations

Cambridge, MA 02139

Posted: 12/20/2024 Employment Type: Contract Job Category: Technology Job Number: 616597 Is job remote?: No Country: United States

Job Description

About Us
This company is a precision therapy company focused on genomically defined cancers, rare diseases, and cancer immunotherapy. We are committed to transforming the lives of patients with complex diseases through our innovative medicines. Our team, known as the Blue Crew, embodies our core values of Patients First, Trust, Optimism, Thoughtfulness, and Urgency in everything we do.
Job Summary
As a Manager in Clinical Systems, you will be part of a team to help support the day-to-day management of clinical systems to support clinical trial operations and regulatory compliance. You’ll be within a dynamic cross functional team and help to support our planning, implementation and user adoption efforts for technologies that enable us to work more efficiently within the company. This position is ideal for a professional who has experience within Clinical Operations, Data Management, Clinical Science, or Quality. We believe that it is a person who has mastered their role and wants to take their career in a new direction. The candidate must have an affinity for technology as this role requires you to know the assigned systems well so you can best support end users (the clinical trial teams). The role requires a customer service-minded individual who can train to all levels.  No day will be alike! On one day you may be head down reviewing specifications and the next day you may be big picture planning with us.

Key Responsibilities
  • Oversee daily operations of clinical systems to support trial management teams, focusing on the clinical data warehouse and IRT/RTSM systems.
  • Act as a business administrator for various clinical systems, including IRT, TMF, and the Clinical Data Warehouse.
  • Collaborate with Quality and IT teams to manage Change Control processes and execute User Acceptance Testing.
  • Ensure data accuracy and integrity as a data steward for clinical systems.
  • Serve as a liaison between Clinical Users/Study Teams and IT, facilitating communication and managing expectations during technology changes.
  • Work with clinical stakeholders to understand their needs and provide user training and support, including creating training materials.
  • Facilitate integration of clinical systems with other IT solutions to meet organizational needs.
 
  • Coordinate with IT, QA, and Clinical Development teams to implement new systems and upgrades, ensuring smooth transitions.
  • Act as the point of contact for stakeholders regarding clinical system functionalities and improvements.
  • Assist in documentation and compliance activities to meet regulatory standards.

Qualifications
  • Bachelor’s degree in life sciences, computer science, business administration, or a related field.
  • At least 3-5 years of experience in clinical systems, clinical operations (or similar role) within the pharmaceutical industry, with a track record of successful project management.
  • Strong understanding of clinical operations and IT infrastructure.
  • Effective leadership and communication skills, with the ability to manage cross-functional teams and projects.
  • Familiarity with clinical trial management systems and regulatory compliance requirements.
  • Proactive and analytical mindset with excellent problem-solving capabilities.
Core Competencies
  • Operational Excellence: Demonstrates the ability to efficiently manage daily operations of clinical systems, ensuring smooth and effective functioning that supports clinical trial activities and compliance requirements.
  • Team Leadership and Development: Possesses leadership qualities that inspire and motivate team members. Capable of managing a diverse team, providing guidance, and promoting professional growth and development within the team.
  • Technical Knowledge and Application: Has a solid understanding of clinical systems technologies and how they integrate with other IT resources to support clinical operations. Skilled in troubleshooting, system enhancements, and ensuring operational stability.
  • Problem Solving and Critical Thinking: Utilizes a systematic approach to solving problems and making decisions. Capable of identifying issues, analyzing potential solutions, and implementing effective resolutions.
  • Communication Skills: Communicates effectively across all levels of the organization. Able to clearly convey technical information to non-technical stakeholders and facilitate collaboration between various departments.
  • Project Management: Exhibits strong organizational and project management skills. Can oversee projects from inception to completion, ensuring they meet deadlines, stay within budget, and achieve desired outcomes.
Regulatory and Compliance Awareness: Understands the regulatory environment relevant to clinical systems in the pharmaceutical industry. Ensures systems and processes comply with all applicable regulations and standards

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.