Clinical Program Manager

EDUCATION & JOB EXPERIENCE

• 7-10 Years with Bachelors (Clinical or Scientific) or 5-8 Years with Masters or 3-6 with Doctorate or 0-3 Years with MD*, DVM* (*Board Certified)
• Proficient knowledge of clinical research study processes and study design; demonstrated ability to incorporate and adhere to Good Clinical Practices and regulatory standards
• Proficient knowledge in word processing, spreadsheets, and/or database applications (e.g., MS Word and Excel)

KNOWLEDGE & SKILLS/COMPETENCIES

·       Knowledge: Applies mastery of in-depth knowledge in one job family or broader expertise in most areas of a job function.

• Problem Solving: Develops solutions to complex problems that require the regular use of ingenuity and creativity. Ensures that solutions are consistent with organization objectives.
• Discretion / Latitude: Work is performed without appreciable direction.  Exercises considerable latitude in determining deliverables of assignment.  Completed work is reviewed from a relatively long-term perspective, for desired results.  May provide guidance about work activities to colleagues.
• Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious impact on customers and/or results and considerable expenditure of resources.
• Liaison: Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs. Leads briefings with internal and external contacts.

DESIRED/PREFERRED QUALIFICATIONS:

EDUCATION & JOB EXPERIENCE

§  Bachelors degree in clinical or scientific related field

§  Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)

KNOWLEDGE & SKILLS/COMPETENCIES

§  Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, CRDM therapies and technologies

§  Project management capability

§  Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical studies

§  Demonstrated ability to identify and implement solutions in addressing study issues

§  Ability to identify customer requirements and manage expectations for clinical studies

§  Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements.

§  Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing

§  Demonstrated ability to identify and adapt to shifting priorities and competing demands

§  Demonstrated ability to maintain composure in difficult circumstances

§  Demonstrated ability to identify and overcome obstacles

§  Ability to constructively respond to feedback from customers and coworkers

§  High attention to detail and accuracy

PHYSICAL REQUIREMENTS:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.