Clinical Project Manager, Internal Medicine

JOB OVERVIEW

Job Profile Summary

Manage the execution of the assigned regionally-based clinical studies per Contract, from initiation through to closeout.Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies, and practices.

Responsibilities

Essential Functions

• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles to ensure consistent use of study tools and training materials and compliance with standard processes, policies, and procedures.
• Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
• Serve as primary project contract with Sponsor to ensure communication is maintained and reporting schedules are adhered to
• Collect information on team performance against contract, customer expectations, and project baselines
• Lead problem solving and resolution efforts to include management of risk, contingencies, and issues
• Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Provide input to line managers of their project team members performance relative to project tasks
• Prepare and present project information at internal and external meetings
• Participate in proposal development and in the bid-defense process with guidance and supervision
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of the CRA team

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

Typically requires 3 - 5 years of prior relevant experience.

Knowledge

Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

Education

Education Level

Education Details

Req

Pref

Bachelor's Degree

Life sciences or related field

X

Additional Work Experience

Experience Details

Req

Pref

5 years clinical research experience including 2 years project management experience

X

Or

Equivalent combination of education, training and experience

X

Skills and Abilities

Skill/Ability

Description

Proficiency

• 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
• Good therapeutic and protocol knowledge
• Strong communication and interpersonal skills, including goog command of English language
• Good problem solving skills
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics
• Excellent customer service skills
• Good presentation skills
• Good judgement
• Strong software and computer skills, including MS office applications
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Standard ADA Settings

The physical demands described here 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

Standard ADA Selection

Office Environment

Physical Demands

Physical Demand

N/A

Rarely

Occasionally

Frequently

Constantly

Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.

X

Use hands and fingers to handle and manipulate objects and/or operate equipment.

X

Travel Requirements

Frequency

Brief Description

May require occasional travel.

The above information on this description has been designed to indicate the general nature and level of work performed.It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job.While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time