Job expirat
As a Clinical study Manager you would manage the execution of the clinical component of large, complex study protocols or global projects in accordance with the scope of work, contracted timelines and study budget. You may also lead other CTLs assigned to the same project and could have some Project Management responsibilities on local or regional projects.
RESPONSIBILITIES
• Establish appropriate clinical tools and processes for the study team to support the execution of clinical deliverable and study timelines.
• Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress. You would report progress to appropriate clinical management and project management forums.
• You would collaborate with other functional groups within the company such as data management, pharmacovigilance, and biostatistics where necessary to support milestone achievement and to manager study issues and obstacles.
• Provide ongoing training and support to the clinical team. Establish study tools and training materials. Conduct frequent team meetings and ensure regular communication. You would mentor less experienced CTLs.
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
• Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Manager. Develop proactive contingency plans to mitigate clinical risk.
• Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings. Implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Track clinical budget consumption through regular review of project budget reports. Escalate out of scope requests to applicable PM and implements corrective action wherever necessary to manager clinical costs.
• Establish customer service relationship with applicable client representative(s) through regular communications.
• May serve on clinical operations task forces and may participate in department/corporate initiatives.
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• In depth therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Strong written and verbal communication skills including good command of English language
• Excellent organizational and problem-solving skills
• Effective mentoring and training skills
• Effective time management skills
• Effective presentation skills
• Ability to lead and motivate a culturally-mixed clinical team
• Ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s degree in a health care or other scientific discipline or educational equivalent; 6 years of experience working on clinical trials including monitoring and 3 years in a project leadership role with expanding cross-regional/global focus; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Frequent domestic and international travel
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.