Sr Clin Data Assoc

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance.

As a Senior Clinical Data Associate you will perform all aspects of the data cleaning process with minimal supervision in accordance with:

• Good Clinical Practices (GCP)
• Standard Operating Procedures / Work Process Documents (SOPs/WPDs)

Your work will support the assessment of the safety and efficacy of investigational products and/or medical devices.

• Support the setup of study activities such as:
  • Database design
  • Testing of data entry screens
  • Data Validation Manual (DVM) creation as required
• Review data listings for accuracy and consistency
• Generate track and resolve data clarifications and queries
• Make changes to the clinical database as required

• Act as point person and subject matter expert for specialized study-specific processes
• Contribute to the improvement of data management processes on a global level
• Understand project protocol and DVM requirements

• Produce project-specific status reports for management and/or clients on a regular basis
• Provide training and work direction to junior staff as required
• Collaborate with project teams while maintaining high quality standards

• Bachelors degree or equivalent and relevant formal academic/vocational qualification

• Previous experience that provides the knowledge skills and abilities to perform the job comparable to 0 to 2 years

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Ability to apply knowledge and skills in a highly organized fashion while adhering to:

• Regulatory guidelines
• Global SOPs
• Client expectations

Strong attention to detail and numerical skills
Good written and verbal communication skills
Good analytical and problem-solving skills
Ability to maintain a high degree of confidentiality with clinical and proprietary client data
Strong customer focus and excellent interpersonal skills
Proven flexibility and adaptability
Ability to set and meet timelines or negotiate schedule changes in response to project demands
Knowledge of medical/clinical terminology
Proven ability in achieving applicable technical competencies per the DM competency grid

• Work is performed in an office environment with exposure to electrical office equipment
• Occasional drives to site locations
• Occasional travel both domestic and international

When you join Thermo Fisher Scientific you become part of a global team that values:

• Passion
• Innovation
• Commitment to scientific excellence

Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.