Clinical Project Manager - San Diego, CA | Biospace
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Clinical Project Manager

Xeris Pharmaceuticals, Inc.

Location:
San Diego, CA
Posted Date:
6/8/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Xeris is an emerging pharmaceutical company dedicated to the development of patient-friendly injectable drugs to address important unmet medical needs while improving patient compliance, lowering total costs of treatment, and having a positive impact on patient and caregiver quality of life. With this singular focus on patient quality of life, each member of the Xeris team is working to develop novel products that improve upon existing products or enable delivery of novel drug substances, allowing for treatments not previously possible.

Position Summary

Xeris is looking for a Clinical Project Manager to join our team in San Diego, California.  The Clinical Project Manager will be responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.

Responsibilities

•   Collaborate with internal and external team members for the planning and execution of clinical trials.
•   Lead/oversee operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly
•   Assist with development and management of project timelines and budgets; help ensure project deliverables are on time and within agreed upon budget and amended accordingly
•   Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan
•   Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
•   Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs)
•   Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
•   Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures
•   Monitor clinical study site activities and visit sites as needed
•   Track, collect, and review clinical documentation for clinical trials or ensure this is being done by CRO or internal staff

Requirements

•   Minimum BA/BS degree in a science/healthcare field, a nursing degree, or equivalent combined education
•   At least 5 years of Clinical Trial Management/Clinical Operations experience required. Experience in endocrinology preferred
•   Must have experience in CRO oversight
•   Excellent Leadership skills; ability to collaborate across disciplines
•   Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations
•   Ability to manage multiple projects and resources
•   Ability to effectively communicate, both verbally and in writing
•   Ability to work independently, and be self-motivated and self-disciplined
•   Some domestic travel required (up to 25%)


Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors