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Clinical Trial Manager

Company: Precigen, Inc.
Location: Germantown
Posted on: June 12, 2021

Job Description:

Precigen is seeking a Clinical Trial Manager (open to all experience levels) to play a key role in the Clinical Operations Team. This position will be primarily responsible for planning and execution of clinical studies of our novel cell and gene therapies across multiple therapeutic areas. The role involves integration across internal and external teams to ensure studies are managed to the highest quality to safeguard the safety and effectiveness of Precigen's products. This will be an onsite role with estimated travel at 5 - 10%.

DUTIES AND RESPONSIBILITIES:

  • Oversee and manage cross-functional team resources and external service providers (including medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.
  • Develop and maintain tracking tools for clinical trials including, but not limited to, site status, enrollment, study and monitoring visits, sample tracking, data entry and review and action items.
  • Support development of study related documents including site feasibility, informed consent documents (site specific), monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals and training materials.
  • Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of clinical trial material.
  • Support study start up in collaboration with internal and external project teams including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection.
  • Identify issues, recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues.
  • Manage external relationships critical to the success of clinical programs including investigational sites, key opinion leaders and other external partners
  • Actively participate in department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.

Final job title and associated responsibilities will be commensurate with the successful candidates' level of expertise.

EDUCATION AND EXPERIENCE:

  • Bachelor's degree, or equivalent, in a biomedical, life science, or related field of study. Equivalent combination of education and applicable job experience may be considered.
  • Minimum 3 years of clinical operations experience in a pharmaceutical or CRO setting or related work experience.
  • Familiarity with GCPs, ICH guidelines and FDA regulations.
  • Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
  • Good problem solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
  • Demonstrated ability to lead and organize team meetings
  • Ability to foster effective relationships with vendors, investigators and colleagues
  • Ability to contribute technical expertise to the various aspects of the clinical trial process.
  • Must be willing to travel domestically and internationally up to 5-10%.

DESIRED KEY COMPETENCIES:

  • Ability to understand and execute on the company's mission and values.
  • Value based collaborator - respectful, accountable and collaborative.
  • Impactful written and verbal scientific communication.
  • Appreciation of diversity and multiculturalism.
  • Ability to build working relations throughout the organization to achieve business goals.
  • Strong time management and organizational skills.
  • Knowledge of First in Human trial management.
  • Experience with oncology and/or auto-immunity disease trials.
  • Experience with cellular therapy trial management.

EOE MFDV

Keywords: Precigen, Inc., Germantown , Clinical Trial Manager, Other , Germantown, Maryland

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