Clinical Trial Manager

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. 

We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

Who are we?
Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate genes, independently or simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs.

Opportunity:
Epicrispr Biotechnologies is seeking an experienced hands-on Clinical Trial Manager to oversee the planning, execution, and management of clinical trials. The ideal candidate will ensure that all clinical studies are conducted in compliance with regulatory requirements, company policies, and industry standards.

Roles and Responsibilities:

• Collaborate with cross-functional teams to establish project objectives, study protocols, timelines, and budgets. Oversee the operational execution of clinical studies from the initial synopsis through final deliverables, ensuring quality, compliance, and a hands-on approach to day-to-day operations.
• Select, train, and manage study sites, fostering strong relationships with investigators and site staff. Play an active role in day-to-day operations to ensure effective trial execution, ensuring all team members are supported and guided appropriately.
• Ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines. Prepare and submit necessary documentation to regulatory authorities.
• Oversee data collection processes and ensure data accuracy. Work closely with the data management team to address discrepancies, providing a hands-on approach to ensure data integrity throughout the study lifecycle.
• Conduct regular site visits, actively monitoring study progress, compliance, and quality. Provide real-time updates to stakeholders on study status, key metrics, and challenges, ensuring no detail is overlooked.
• Manage study budgets, including forecasting, tracking expenses, and ensuring timely payments to vendors and sites. Take an active role in overseeing resource allocation and vendor selection, ensuring financial and operational efficiency.
• Lead, mentor, and manage clinical trial teams, fostering a hands-on, collaborative, and productive work environment. Ensure effective communication and coordination among cross-functional team members to drive successful trial outcomes.
• Identify and mitigate risks early, prioritizing tasks to ensure the successful accomplishment of study objectives. Provide leadership and oversight in resolving any issues that arise during the course of the study.
• Effectively track and communicate program and study progress to Senior Management, utilizing detailed dashboards and trackers. Be actively involved in the preparation of reports and meetings, ensuring transparency and proactive communication.
• Stay informed of changes in regulations, guidance, and the competitive landscape, assessing their impact on clinical projects. Adjust operational strategies and protocols as necessary, ensuring projects remain aligned with regulatory expectations.

Qualifications:

• Bachelor’s degree with 6+ years of pharmaceutical or biotech-related/clinical research, research experience
• Experience in project management with a strong cross-functional approach, coupled with a people-oriented mindset and a positive attitude, is highly desirable.
• Must have extensive experience in managing Phase 1 and Phase 2 clinical trials, specifically for rare diseases, with a demonstrated ability to manage complex studies from start to finish.
• Prior experience with early-phase clinical studies, particularly those involving complex protocols, is highly desirable.
• Experience in neuro-muscular-related fields is beneficial.
• In-depth knowledge of gene therapy research, methodologies, and regulatory considerations. Experience managing trials involving gene therapy is highly preferred.
• Exceptional organizational and project management skills, with the ability to manage multiple tasks and stakeholders while meeting tight deadlines.
• Strong knowledge of GCP, FDA regulations, and other relevant guidelines.
• Proven track record of managing multiple studies simultaneously and delivering results on time and within budget.
• Excellent communication, organizational, and leadership skills.
• Proficiency in clinical trial management software and data management systems.
• Ability to anticipate and resolve issues proactively, ensuring successful trial execution and delivery.

Compensation: The salary range for this position is $126,000 to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.