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(Contractor) Clinical Trial Manager

Date:  Nov 23, 2022
Location: 

St. Louis, MO, United States

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

 

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

 

Summary of Position

The Clinical Trial Manager (CTM) is responsible for all aspects of the clinical trials for which they are assigned under the direction of the Director of Clinical Operations Director.  This person is accountable for  achieving successful delivery of Curium clinical trial activities by meeting company and regulatory requirements.

Essential Functions

  • In line with the CRO, oversee, support, and conduct study start up activities including Site outreach, Site feasibility, Site qualification, Site contract/budget negotiations, regulatory submissions, and any other start up related activities
  • In concert with the Clinical Operations Director, review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
  • Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
  • Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CROs as applicable.
  • In collaboration with the Clinical Operations Director, oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and EDC queries.
  • Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives.
  • Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • In collaboration with the Clinical Operations Specialist, perform financial management, including review and approval of site and vendor invoices, investigator contracts and site payments. And track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
  • Serve as a liaison and resource for investigational sites.
  • Organize and manage internal team meetings and other trial-specific meetings
  • Other responsibilities as assigned.

Requirements

  • Bachelors or Masters degree or equivalent in a scientific or health care field is required.
  • Minimum of 8 - 12 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.
  • Experience in running a trial from start to finish is preferred.
  • Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
  • Strong team orientation, with excellent written and oral communication skills and interpersonal skills.
  • Read, write and speak fluent English; excellent verbal and written communication skills
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data methods.
  • Must be proficient in Microsoft Office tools.
  • Dedicated organizational and time management skills are required

 

Working Conditions:

  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Willingness to work in a team based, collaborative environment. 
  • May be required to sit or stand for long periods of time while performing duties. 
  • Responsibilities also include the ability to walk, bend, stoop, kneel, crouch, crawl, twist upper body, push, pull, reach, and climb stairs with or without accommodation. 

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 


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