Clinical Project Manager/Senior Clinical Project Manager

Proclinical is currently seeking a Clinical Project Manager/Senior Clinical Project Manager for a biopharmaceutical company located in Rockville, MD. This role will be key in developing internal Clinical Operations systems and procedures to improve all aspects of Clinical Study related business processes and will work very closely with the Associate Director of Clinical Operations along with the US Site Head.

Job Responsibilities

• Participating in planning, implementing and managing of pre-IND through Phase I-II clinical trials.
• Managing day to day activities of all aspects of clinical studies.
• Contributing to development of RFPs and participating in selection of CROs/vendors.
• Managing CRO and vendor activities.
• Providing updates on project status and deliverables to Clinical Project Management leads.
• Overseeing investigator recruitment/selection and the conduct of trials at investigative sites.
• Participating as necessary in monitoring visits, reviewing monitoring visit reports and ensuring CRO quality within trials.
• Planning, executing, and leading Investigators Meetings.
• Developing relationships with Key Opinion Leaders as applicable for key I-Mab development programs.
• Preparing and presenting study or project specific updates.
• Representing Project Management & Clinical Operations in partnered development programs.
• Mentoring junior level Clinical Research Associates.

Skills and Requirements

• Life sciences or medical background is required.
• 6+ years of industry experience (biotech/pharma) with 2-5+ years of project management experience.
• Experience in Phase 1 Oncology trials.
• Strong understanding of ICH, GCP and relevant regulatory requirements.
• The ability to work with cross-functional teams in a matrix environment is a must.
• Strong organizational and time management skills; detailed oriented; excellent interpersonal and communication skills.
• Proficiency with Microsoft Office Suite and MS Project.
• Ability travel domestically and/or globally up to 20 - 30% of time.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Natasha Patel at (+1) 617-778-7319 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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