ClinDatrix is looking to hire a full time in-house Clinical Project Manager. Ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
Responsibilities • Responsible to plan, coordinate and manage the day-to-day clinical study operations that meet the goals and objectives of the Sponsor while adhering to all ethical, medical, regulatory, and ClinDatrix requirements. • Prepare study timelines and budgets. • Act as a primary liaison to the Sponsor and regularly communicate with the project team (clinical and other departments internal and external to ClinDatrix) and the Sponsor to provide updates on the progress of the clinical trial. • Liaise with Data Management to review discrepancies and ensure that data clarification forms (queries) are appropriately answered and returned by the investigator(s) and clinical site(s) in a timely manner. • Maintain appropriate contact with the clinical sites to assure study progress and resolution of problems or misconceptions, and also to discuss general and specific study aspects. • Responsible for the review of all study-related documentation (e.g., Trial Master File, visit reports, clinical monitoring plan, informed consents) during study start-up and throughout the project to ensure that procedures are followed in an appropriate and consistent manner. • Initiate and supervise documentation preparation for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, Protocol Specific Procedures (PSPs), Newsletters, etc. • Ensure that study sites are monitored appropriately, in a professional manner, and in a timely fashion. • Develop and maintain appropriate academic knowledge and practical experience necessary to conduct the job in a professional and competent manner, and become familiar with current knowledge, practice, and capabilities in relevant fields of science/medicine and in federal regulations. • Assist with production of Clinical bids in order to win major project awards for ClinDatrix, Inc. • Assist with generation of the Clinical Project budget. Manage all project expenditures related to the project. Review and approve project time reporting, expense reports, and project related expenditures (if applicable) of direct reports. • Organize and train a project team who will assist in executing the clinical study. • Supervise clinical staff to ensure all study activities are performed in a professional manner, and in accordance with the protocol and applicable regulations, e.g., GCP and SOPs. • Provide leadership and development support to the clinical team.
Qualifications and Requirements • Bachelor’s degree with 5 years of clinical research or pharmaceutical industry work experience; or Master’s degree with 3 years of clinical research or pharmaceutical industry work experience; or PhD/PharmD/MD with 1 year of clinical research or pharmaceutical industry work experience. • Knowledge of Good Clinical Practices (GCP), clinical trials management, site monitoring, regulatory compliance, and clinical data management. • Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, sponsor representatives, consultants, team members and various audiences. • Strong organizational skills with ability to multitask and plan activities as it relates to management of clinical trials. • Financial management skills as applicable to overseeing project expenditures and forecasts. • Ability to problem solve, build teams, and to lead and motivate others. • Advanced computer skills (Word, Excel, PowerPoint). • Effectively work independently as well as within a team matrix. • Willing and able to travel.
Internal Number: 001
About ClinDatrix, Inc.
ClinDatrix, Inc. is a privately held, full-service contract research organization (CRO) founded in 2002 to help drug and medical device innovators advance their therapeutic products toward regulatory approval. Over the past two decades, ClinDatrix has grown to offer contract research expertise from preclinical development guidance through regulatory filings and post-marketing studies. We continue to work primarily with small to mid-sized companies, which is a subset of biomedical innovators that we know and serve very well. We also are a reliable resource to large pharma and medical device companies seeking to outsource specialized tasks for timely completion.