Senior Clinical Monitoring Associate



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The responsibility of a Senior Clinical Monitoring Associate is to independently perform and organize remote clinical monitoring tasks and remote visits for designated projects in accordance with relevant SOPs, study specific guidelines and regulations. Responsibilities include managing/ /supporting clinical monitoring activities remotely, including but not limited to issue resolution, patient enrollment management, handling protocol- and/or contract amendments, and ensuring timely/high quality data entry at a site level.

Key Accountabilities
- Assume the ability to meet the requirements of a CMA I and II with a high degree of proficiency and autonomy
- Shows solid understanding of therapeutic indications and study hypothesis
- Manage remote site management activities
- Direct team members in daily activities
- Define and monitor metrics and modifies plan accordingly
- Mentor project- and local team members
- Recognize out of scope activities and communicates to Clinical Operations Leader
- Keeps manager(s) informed about work progress and any issues to avoid surprises. Requires minimal supervision by Manager
- Apply knowledge across multiple projects
- Identify inconsistencies and inefficiencies in processes and recommends solutions

 Excellent interpersonal, verbal and written communication skills
- Excellent computer skills including but not limited to the knowledge of a Clinical Trial Management Systems, Electronic Document Management System, EDC, IWRS, MS-Office products such as Excel, Word.
- Strong awareness of all relevant regulations, including GCP
- Posses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock
- Carefully weighs the priority of project tasks and directs team accordingly
- Understands the strengths and development areas of team members
- Gives others appropriate latitude to make decisions
- Looks for win-win solutions to solve problems
- Ability to make appropriate decisions in ambiguous situations
- Ability to solve problems by using a logical, systematic, sequential approach
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high quality work
- Enlists the support of team members in meetings goals
- Proposes new approaches, methods or technologies
- Anticipates how others will react to situations
- Plans and delivers verbal and written communications that persuade the intended audience
- Willing and able to travel occasionally as required – local or international

- Bachelor’s degree and / or other medical / biological science qualification or relevant working experience

Language Skills
- Excellent in written and oral English

Minimum Work Experience
- Previous relevant working experience preferred, or data management, clinical and / or research experience with solid understanding of clinical trials methodology and terminology
Additional Information
Location | | | Uxbridge Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013

Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided


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