POSITION SUMMARY:This Senior Manager, Clinical Trial is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization non-invasive molecular diagnostic tests. This role manages clinical operations staff and all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management.
PRIMARY RESPONSIBILITIES:- Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors
- Manage and coach clinical research staff.
- Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.
- Partner with department head to develop department procedures and develop infrastructure.
- Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.
- Train CROs, vendors, investigators and study coordinators on study protocol and relevant
- Monitor and track clinical trial progress and provide status update to stakeholders.
- Partner with other research and development groups to achieve deliverables.
- This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
- Must maintain a current status on Natera training requirements.
QUALIFICATIONS:- Bachelor's degree in life sciences, other relevant discipline, or equivalent required. Advanced degree preferred.
- 5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role.
- 2+ years of experience of managing staff. Experience in managing CROs is preferred.
- Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, sample management, and recruitment site management.
KNOWLEDGE, SKILLS, AND ABILITIES:- Familiar with the clinical research regulations.
- Ability to collaborate with the study team, cross functional team members and external
- Proficiency in MS Word, Excel and PowerPoint.
- Good organization and planning skills.
- Strong interpersonal skills and communication skills (both written and oral).
- Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$141,300-$176,600 USD
