Clinical Program Manager

The Clinical Program Manager is responsible for the planning, organization, and implementation of domestic and global clinical trials for cellular therapies and interacts with contractors, clinical investigators, and consultants to ensure compliance with FDA and international regulations, GCPs, and SOPs, and program data quality and efficiency.

• Lead the selection and management of a Clinical Research Organization
• Lead regular Clinical Project Team meetings with CRO team
• Lead the clinical team responsible for the startup and follow-up activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management forums.
• Lead the operational teams needed to successfully enroll the study
• Oversee in the development of Case Report Forms, IND Annual Reports, and IND Safety Reports
• Establish the appropriate clinical tools and processes for the study team to support the execution of clinical deliverable and study timelines.
• Collaborate with other functional groups within or outside the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Establish study tools and training materials.
• Conduct team meetings and ensure regular communication. Mentor less experienced clinical staff.
• Ensure collection of high quality data in line with objectives of the study through the scheduling of co-monitoring/visits with the CRO
• Maintain high quality relationship with clinical investigators, nurses, cell processing laboratory heads, and their staffs through regular communication and support
• Develop and maintain effective working relationships with members of other groups involved in the drug development process
• Develop and negotiate contracts with external vendors (e.g. drug supply, distribution, shipping, and central labs)
• Participate in the identification and selection of new investigators
• Flexibly participate in other aspects of drug development process during the product lifecycle


• Superior interaction skills and ability to work with various groups of people across departments within Osiris and with all collaborators.
• Excellent problem solving skills
• Demonstrated ability to deliver results
• Ability to work under limited direction
• Ability to present clinical program, strategy, and data.
• Ability to contribute to and supervise the development of clinical documents such as study protocols, CRFs, IND Annual Reports, Safety Reports, and study procedures manuals
• Knowledge and understanding of GCP, and cGMP.
• Familiarity with FDA, ICH, and HIPAA rules, regulations, and guidelines for the conduct of clinical trials
• Ability to travel up to 60% of the time.

PREFERRED:

• Minimum of Bachelor's degree in a scientific related discipline
• Minimum of three (3) years experience assisting in the execution, monitoring and managing of Phase 1-3 clinical trials in a pharmaceutical, biotech or clinical research organization
• Previous experience working in a lead clinical position preferred
• Ability to influence decisions within the project and manage timelines
• Proficiency in Microsoft Office Suite
• Ability and desire to work in a team-oriented environment


Osiris Therapeutics is an Equal Opportunity Employer.


If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=509919-3-713