Work Schedule
Standard (MonFri)
Environmental Conditions
Office
Job Description
Join us to advance science conduct clinical trials worldwide and improve health outcomes.
Summarized Purpose
The CDS ensures timely accurate data reviews and serves as the main contact for data activities.
Essential Functions
- Independently own the development and implementation of results including data collection tools data review tools centralized statistical monitoring tools data validation manual inclusive of centralized monitoring activities highquality data for key results such as interim analysis and database lock.
- Ensure data reviews are completed ontime with more complex analyses or deeper root cause analyses to connect related signal to risk. Lead highquality report development.
- Participate in crossfunctional risk assessment review meetings and contribute to overall risk planning. Contribute to risk assessment through the completion of the department risk assessment tools. Monitor and analyze study metrics and advances as per the organizations risk management processes.
- Lead data review meetings inclusive of reviewing trends outliers highrisk sites.
- Mentor juniorlevel staff on all associated tasks within a study and delegate appropriate data reviews that match the experience level.
- Assist with administrative oversight for allocated projects.
- Communicate with management regarding all activities within their studies.
- Investigate and contribute towards the development of innovative technologies to support all aspects of clinical delivery but especially relating to data collection and data review.
Education and Experience
Bachelors degree or equivalent experience and relevant formal academic/vocational qualification. Previous experience equivalent to 8 years in clinical monitoring centralized monitoring data management biostatistics or related field is preferred. An equivalency of education training or related experience may suffice in meeting role requirements.
Knowledge Skills and Abilities
- Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines SOPs and client expectations.
- Strong attention to detail with proficient organization and multitasking skills.
- Excellent analytical/problemsolving skills/judgment in decision making.
- Ability to lead empower and coordinate teams including coaching/mentoring team members.
- Ability to maintain a high degree of confidentiality with clinical data and clients proprietary data.
- Sound interpersonal skills with proven flexibility and adaptability to changing situations.
- Proven track record of clear English communication with project team management and clients.
- Strong computer skills with strong knowledge of MS Office (Word Excel PowerPoint) and the ability to learn and use interactive computer systems.
- Ability to extract pertinent information from standard study documentation such as protocols electronic study data systems and to identify trending of site/study data.
- Excellent knowledge and application of resource management and planning.
- Knowledge of the key components of project management principles of Time Cost Quality.
- Applies a range of negotiation techniques with evidence of commercial and organizational competence to effectively negotiate (persuade convince influence) and achieve desired outcomes internally and externally.
- Demonstrated ability to serve as a subject matter authority and lead on projects crossfunctionally including delegating and effectively prioritizing individual and team workload.
Physical Requirements / Work Environment
- Work is performed in an office/remote environment with exposure to electrical office equipment.
- Daily interactions with clients/associates.
- Varied hours on occasion/ Travel required occasionally domestic and/or international.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Be part of a 100000 strong team with shared values and goals.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.
Accessibility/Disability Access
Thermo Fisher Scientific assists job seekers needing accommodations in the application process.
- This phone line is only for disabled job seekers needing help with accessibility in the application process.