Current Openings

Conduct and report onsite monitoring visits. Responsible for site communication and site management.  Manage study activities, timelines, and schedules.

Qualifications:

·  Degree in Life Sciences or equivalent experience.

·  Strong independent on-site monitoring experience Phase I - IV.

·  Experience in multiple therapeutic areas. (Vaccine experience a plus)

·  Proficiency in MS Office applications.

·  Ability to plan, multitask and work in a dynamic team environment.

Provide clinical leadership to project teams and manage the day-to-day clinical operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations. You will work proactively to mitigate risk and solve potential challenges.

Qualifications:

• Minimum of 3 years experience as a CTM.
• Prior experience as a CRA.
• Experience in multiple therapeutic areas. 
• Global experience a plus.

Conduct and report onsite monitoring visits. Responsible for site communication and site management.  Manage study activities, timelines, and schedules.

Qualifications:

·  Degree in Life Sciences or equivalent experience.

·  Strong independent on-site monitoring experience Phase I - IV.

·  Experience in multiple therapeutic areas. (Oncology a plus)

·  Proficiency in MS Office applications.

·  Ability to plan, multitask and work in a dynamic team environment.

Lead clinical trials from start up to close out.  Oversee and manage projects to ensure clinical trials are completed in a timely manner and within budget.

Qualifications:

·  Bachelor’s Degree or higher.

• Minimum 2 years of Project Management experience.
• Previous experience with a CRO preferred.
• Experience with Phases I-IV from start-up to close-out preferred.
• Knowledge of SOPs, ICH / GCP and local regulations.
• Strong communication, organizational, management and analytical skills.

Prepare clinical documents including: clinical summaries of marketing applications, integrated summaries of safety and efficacy, CSR's, study protocols, IB's, aggregate safety reports, and manuscripts.

Qualifications:

• Bachelor’s Degree or higher.
• Min 5 years of medical writing experience.
• Working knowledge of ICH and other regulatory guidelines required. 
• Ability to present clinical data, strong communication skills.
• Strong regulatory writing skills and keen attention to detail required.

Collaborate with clinical operations, statistics, data science staff, and external partners to ensure accurate, documented, and regulatory-compliant data.

Qualifications:

• Bachelor's Degree or higher.
• 3+ years of clinical data management experience in a life sciences organization.
• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
• Experience  with CDISC standards including SDTM and EDC software.
• Strong organization skills and attention to detail.