CLINICAL PROGRAM MANAGER Cytochroma, Inc.

Job Purpose:

Independently organize and manage multiple tasks related to clinical development programs of varying type and complexity; while simultaneously ensuring study milestones are met and completed according to the protocol, regulatory requirements and Cytochroma standard operating procedures. The CPM will independently oversee the execution of multiple clinical studies for a regional or global clinical programs, generally for a single indication, defined by clinical and business development plans and regulatory strategy approved by Cytochroma Executive Management. The CPM oversees the primary management of clinical studies through direct supervision of Sr. Clinical Trial Managers (Sr. CTMs)/Clinical Trial Managers (CTMs)/Clinical Research Associates (CRAs)/ Clinical Trial Associates (CTAs), Regulatory Document Specialists (RDSs) and CRO/vendor staff.

Duties and Responsibilities:

Lead development and management plans for overall execution of assigned clinical program(s) to meet necessary quality, budget and timelines (Phase I-IV)
Oversee the proper selection and supervision of CRO(s) and other vendors to meet obligations set out in ICH-GCP and associated Regulatory requirements
Ensure adequate internal and external resource planning to achieve program objectives
Lead the cross-functional working groups (internal and external members)
Provide expert input to the design of protocols to ensure operational feasibility and objectives are met
Oversee and manage the Sr. CTM/CTM day-day activities to execute individual studies.
Perform regular performance assessment of CTMs/CRAs/CTAs and RDSs
Oversee CRO and all clinical vendor selection and budget/ contract negotiation with CTM
Ensure the proper supervision and performance of all activities assigned to a CRO
Review and approve study enrollment models, reviews recruitment and enrollment progress development by CTM and CROs
Provide regular program status updates to line management and to Executive Management as requested
Identify alternate clinical strategies to address enrollment issues and work with appropriate functional groups or CRO to address
Provide mentorship and training to Clinical Trial Managers and new hires
Participate on Clinical Development/Affairs functional teams to develop innovative processes and technologies to advance operations and manage operating costs
Represent Cytochroma at internal and external meetings, including Investigator Meetings
Develop professional working relationships with key opinion leaders in pharmaceutical operations

Qualifications:

Demonstrated expertise in Good Clinical Practices, ICH Guidelines and appropriate regulations
Demonstrated project management skills
Demonstrated organizational and teamwork skills
Excellent interpersonal, negotiation and influencing skills
Demonstrated experience in critical-thinking, prioritization and problem-solving skills
Excellent written and verbal communication skills
Minimum Bachelors Degree required, life sciences preferred. M.Sc. or higher degree preferred.
Minimum 7 years of clinical development or trial experience in pharmaceutical industry and/or CRO required.
Minimum 5 years clinical trial management experience in Phases I through III required.
Experience managing multiple late studies or cross-regional/global studies preferred.
Track record of delivering clinical trials to time, quality standards and budget
Willing and able to travel (up to 40) to various meetings at investigator, vendor or regulatory agency locations, including some international travel as may be required

Location:	Bannockburn, IL United States