FSP Clinical Data Strategist
ThermoFisher Scientific
**Work Schedule**
Standard (Mon-Fri)
**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, high-quality data for key results such as interim analysis and database lock.
+ Ensure data reviews are completed on-time with more complex analyses or deeper root cause analyses to connect related signal to risk. Lead high-quality report development.
+ Participate in cross-functional 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 organization's risk management processes.
+ Lead data review meetings inclusive of reviewing trends, outliers, high-risk sites.
+ Mentor junior-level 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**
Bachelor's 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 multi-tasking skills.
+ Excellent analytical/problem-solving 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 client's 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 cross-functionally, 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, forward-thinking 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 100,000+ strong team with shared values and goals.
**Apply today! http://jobs.thermofisher.com**
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.
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.
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