Clinical Trial Manager
Company: Precigen, Inc.
Posted on: June 12, 2021
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
- 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
Final job title and associated responsibilities will be
commensurate with the successful candidates' level of
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
DESIRED KEY COMPETENCIES:
- Ability to understand and execute on the company's mission and
- Value based collaborator - respectful, accountable and
- 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
- Experience with cellular therapy trial management.
Keywords: Precigen, Inc., Germantown , Clinical Trial Manager, Other , Germantown, Maryland
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