We have a permanent opportunity for a Clinical Project Manager for a growing client in the Washington, D.C. area! (Spine, Medical Device, Clinical Trials)
We are seeking a Clinical Project Manager to provide project management for our clients’ IDE & IND clinical studies. The Clinical Project Manager’s main duties will be to provide leadership and project management for clinical trial activities. This will include planning, implementation, and tracking of clinical monitoring processes, administration of clinical trials and maintaining an overview of the clinical trials. The candidate will actively oversee the monitoring, data and safety plans.
Responsibilities & Duties
– Manage, execute, and properly resource Phase I-IV of clinical trials in accordance with timeline and quality standards
– Assure studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
– Approve study documents such as clinical protocols, ICFs, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manuals, Patient Diaries, Study Reference Binders, Pharmacy Manuals, Clinical Data Review Plans, clinical database specifications, Clinical Study Reports (CSR), etc.
– Maintain positive relationships both internally and externally
– Track and report on progress of study including site activation, patient enrollment, and monitoring visits
– Develop Clinical Monitoring Plan and other project documents as assigned
– Manage clinical monitoring functions of clinical studies
– Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
– Assist with professional development for Clinical Research Associates and Clinical Associates.
Required Knowledge, Skills, & Experience
– BA/BS or equivalent degree in scientific discipline.
– Expertise in regulatory requirements for managing Phase I-IV studies
– Minimum 4 years’ of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting
– Prior experience with monitoring/working as a CRA
– Previous trial management experience to include:
– Responsibility for the management and execution of the clinical project.
– Execution of the Monitoring Plan in consultation with the cross-functional project team, clients and the clinical team.
– Presentation of project plans, ongoing updates and project results to management.
– Oversight of clinical projects to ensure safety concerns, adverse events, or trends in Safety Reporting are identified and appropriate responses are developed and executed.
– 1+ years of supervisory experience
– Experience/knowledge as a project manager in medical device studies, preferably spine device studies
– Advance degree (MA/MS, PharmD, PhD)
– Certified Clinical Research Professional (SoCRA or ACRP)
For IMMEDIATE consideration, please email your resume to [Click Here to Email Your Resum] with the subject line ‘Sr. Trial Manager’!
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resum] or ************.
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Apex Life Sciences
On Assignment’s U.S. life sciences businesses, Lab Support and Valesta Clinical Research Solutions, have been re-branded as Apex Life Sciences. The U.S. divisions of Lab Support and Valesta are leaders in the scientific, engineering, and clinical research staffing and services industry. The new name was chosen to leverage the national brand of On Assignment’s Apex Systems, a leader in the technology staffing and services industry. For over 30 years, Lab Support and Valesta have provided top talent for contract, contract-to-hire, and direct hire positions in the life sciences industries. With hundreds of thousands of successful matches over three decades, the divisions have built reputations as the best in the business. Contact Info
– Washington, DC
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