Clinical Trials Manager - late phase

ProClinical is announcing a vacancy for a Clinical Trials Manager with a leading biopharmaceutical company. Based in the US, this company prides itself on its extensive portfolio of life-saving drugs within a number of therapy areas. The Clinical Trials Manager will join this team in their California office on a contract basis.

Job Responsibilities:

• Critically evaluating scientific proposals, protocols, and budgets for clinical operation feasibility and fair market value assessment.
• Establishing strong partnerships with external investigators and collaborators to ensure ongoing activities for CO and ISR studies are executed in a timely manner to a high quality.
• Establishing strong cross-functional relationships and exhibiting strong leadership skills with counterparts in other functional teams (e.g., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes.
• Proactively identifying potential operational challenges and in collaboration with senior team members, providing resolution plans to ensure study remains on track.
• Implementing and maintaining industry standards and regulations for CO and ISR studies and keeping abreast of any new changes and developments impacting Late Phase clinical operations.
• Coordinating data listing reviews and preparing interim/final clinical study reports.
• Assisting in determining the activities to support a project's priorities within functional area.
• Training CROs, vendors, investigators, and study coordinators on study requirements.
• Contributing to the development of study budget.
• Examining functional issues from an organisational perspective.
• Collaborating with local medical affairs colleagues on country specific studies and initiatives.
• Providing knowledge and expertise on country specific regulations, site experience, and suitability for development studies.

Skills and Requirements:

• At BS or BA in a relevant scientific discipline, or an RN (2 or 3 year certificate).
• At least 5 years of demonstrable experience.
• Thorough knowledge of FDA and/or EMA Regulations, or relevant local regulations, along with ICH Guidelines and GCP governing the conduct of clinical studies.
• Proficiency with MS Office.
• Strong interpersonal skills, including communication, persuasion, and motivation.
• Excellent teamwork, decision-making, and organisational skills.

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 Sherron Howard on + 267 435 8600 or upload your CV 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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