CLINICAL TRIAL MANAGER
This is a fulltime in-house position located in San Bruno, CA. This role will be responsible for overseeing and developing the clinical operations and administrative staff. This position will report to the director of clinical operations and will be responsible for the direct reports as well as have some duties involving Sponsor contact. This position may have occasional travel for training, mentoring and hands on evaluation of regional staff.
Description of job duties:
- Line management of in-house staff and regional Clinical Research Associates (CRAs)
- Team advocate to ensure appropriate responsibility and accountability of all team members
- Recruit and screen for the hiring of additional staff
- Training and development of clinical staff of protocols, medical and scientific study areas, good clinical practices and other industry standards
- Oversight and Management of CRAs to ensure Sponsor satisfaction and expectations are met
- Tracking and management of CRA resourcing/allocation of project assignment and work-load
- Manage turnover and retention of CRAs to meet PRC and sponsor objectives
- Other related duties as necessary
- Bachelor’s degree with 4-6 years pharmaceutical industry experience (site monitoring project management) including direct supervisor experience;
- Understanding of Good Clinical Practice and regulatory environmentStrong leadership, mentoring, and motivational skills;
- Effective written and verbal communication skills;
- Current business software skills
- Competitive salaries, incentive bonus and a full range of benefits including: Medical, dental, life, disability insurance coverage, 401k with generous match, PTO and bonuses based on yours and
- PRC’s performance and access to the onsite fitness center.
- 7+ years CRA experience in oncology, neurology, pulmonary, or infectious disease, working knowledge of regulatory and drug development process, data management and EDC, and exposure to the contracts/budget process.
- This position will interact with other teams and departments and act as the primary contact for vendors/CRO giving technical guidance and direction to external team members and vendors.
- The CRA will contribute to the overall study team and perform the usual functions of an in-house CRA including assist with the development of the study plan, reviewing informed consents, site-monitoring, site budget and payments; reconcile differences in site data; proactively monitor site supply requirements; recognize and propose resource needs; produce accurate and well-represented documents.
1099/W2 positions available – full time and part time work. Some travel may be required.
CLINICAL PROJECT INTERNSHIP
Get the experience necessary to enter the pharmaceutical and biotech clinical research industry. You will gain valuable experience from the CRO to Sponsor perspective. Some of the job duties include: making client regulatory and SOP binders, participating in meetings and teleconference, administrative support, updating spreadsheets, and communication with investigator sites as well as pharmaceutical and biotech sponsors.
Requirements: BS degree. Proficiency with MS Office. Clinical knowledge, past/current enrollment in an Clinical Trials Design education program is helpful.