RemoteWLBRemote only
Back to all jobs
Natera logo
Remote role · senior-m

Senior Manager, Clinical Trial

Natera

Austin, TXManagement
Role brief

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 junior clinical research staff (e.g. CRA, CTA)

  • 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.

  • 1-2 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, 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.