Contract Clinical Program Manager Quark Pharmaceuticals
THIS JOB HAS EXPIRED Quark is looking for an organized, detail-oriented Clinical Program Manager (CPM) to join the clinical operations team in the Fremont, CA In this role, the CPM will work approximately 30+ hours per week.
Manage day to day activities and timeline for the close-out of a North American Phase 2 kidney transplant trial (approximately 330 patients and 35 clinical sites).
Manage the clinical CRO involved in the trial.
Convene and lead cross functional clinical team meetings.
Review trip visit reports, site communications.
Oversee study Trial Master File reconciliation.
Work closely with the Medical Monitor, Drug Safety, Clinical Data Management, Regulatory/QA, etc. as well as other cross-functional team members/clinical CRO staff to ensure successful completion of all clinical activities/project deliverables within agreed upon time frames.
Some limited travel may be required.
Basic Qualifications/Work Experience
Bachelor?s degree in health related science and/or nursing degree (RN), and/or pharmacy degree or equivalent experience is required.
At least 5 years of clinical operations work experience and a working knowledge of GCP/ICH guidelines and the clinical development process.
Experience as a CPM - at least 2 years of team leadership experience.
Experience in project-managing study close-out activities and database lock of large industry sponsored clinical (pharmaceutical) programs.
Previous experience working with an electronic data capture system required, Medidata preferred.
Excellent people skills and team oriented.
Effective written and verbal communication skills.
Comfortable working in a fast-paced, dynamic work environment.
Detail-oriented with strong organizational skills.
Computer skills with advanced working knowledge of Microsoft Word, Excel, Outlook and PowerPoint.
Demonstrated ability to work independently as well as part of a multi-functional study team.
Able to motivate a team to work effectively under a changing environment.
Self-motivated and able to work effectively in a matrix/team environment.
||6501 Dumbarton Circle |
Fremont, CA 94555
THIS JOB HAS EXPIRED