Clinical Trial Manager (Hybrid)
- Posted: over a month ago
Precigen is seeking a Clinical Trial Manager to play a key role in the Clinical Operations Team. This position will be primarily responsible for planning, execution and oversight 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 according to ICH E6 (R3) Guideline for Good Clinical Practices, Code Federal Regulations to safeguard the safety and effectiveness of Precigen’s products.
We are open to this role being hybrid, with onsite time in our Germantown, Maryland office.
Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons.
DUTIES AND RESPONSIBILITIES:
- Oversees and manage cross-functional team resources and external service providers (including, but not limited to medical monitoring, safety, legal, regulatory, 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, forecast vs actuals, site status, enrollment, study and monitoring visits, sample tracking, data entry and review and action items.
- Accountable for the 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.
- Collaborate with internal and external project teams to ensure successful study startup according to project timelines, to include, but not limited to, budget and contract negotiations and execution, 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.
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 10-15%.
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
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