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FSP Clinical Data Strategist

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.
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Average salary estimate

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$90000K
$120000K

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What You Should Know About FSP Clinical Data Strategist, Thermo Fisher Scientific

Are you ready to elevate your career as an FSP Clinical Data Strategist with Thermo Fisher Scientific in beautiful North Carolina? We're all about advancing science, conducting impactful clinical trials, and ultimately improving health outcomes. In this role, you'll get to take the lead on developing and implementing essential data collection and review tools, ensuring our data is not just accurate but of the highest quality. Be the main contact for data activities, working closely with cross-functional teams to assess risks and analyze study metrics. You’ll enjoy mentoring junior staff and guiding them through vital processes, ensuring our team operates like a well-oiled machine. With your 8+ years of dedicated experience in clinical data management, you'll find plenty of opportunities to innovate and make a real difference in clinical delivery. We value attention to detail, strong analytical skills, and effective communication in this office-based position that may involve some travel. Join our thriving, values-driven culture and contribute to exhilarating advancements in science and health. Apply today and be part of a team that stands for integrity, involvement, and innovation!

Frequently Asked Questions (FAQs) for FSP Clinical Data Strategist Role at Thermo Fisher Scientific
What are the responsibilities of an FSP Clinical Data Strategist at Thermo Fisher Scientific?

As an FSP Clinical Data Strategist at Thermo Fisher Scientific, your primary responsibilities include managing data collection tools and review mechanisms, leading high-quality report development, participating in risk assessment review meetings, and mentoring junior staff. You will also be tasked with ensuring that data analyses are conducted on time and align with organizational processes. In essence, you'll play a pivotal role in maintaining the integrity and quality of our clinical data.

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What qualifications are needed for the FSP Clinical Data Strategist role at Thermo Fisher Scientific?

To qualify for the FSP Clinical Data Strategist position at Thermo Fisher Scientific, you should ideally have a Bachelor's degree or equivalent experience, alongside at least 8 years in clinical monitoring or related fields. Your experience should cover data management and biostatistics, with a strong understanding of regulatory guidelines and project management principles. Excellent analytical and leadership skills are also essential to succeed in this role.

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How does Thermo Fisher Scientific ensure data accuracy in clinical trials?

Thermo Fisher Scientific ensures data accuracy in clinical trials through the development and implementation of robust data review and validation processes. As an FSP Clinical Data Strategist, you will lead rigorous data reviews, conduct complex analyses, and participate in cross-functional risk assessments to identify and mitigate risks early. Your work will be instrumental in maintaining the highest quality standards for clinical data.

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What opportunities for career development are available for an FSP Clinical Data Strategist at Thermo Fisher Scientific?

Thermo Fisher Scientific offers a wealth of opportunities for career development for an FSP Clinical Data Strategist. You'll benefit from an innovative company culture focused on your professional growth, mentorship programs, and the chance to work on cutting-edge technologies in clinical delivery. This role is an excellent stepping stone for further advancement within the organization, supported by various training and development resources.

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What does a typical work environment look like for an FSP Clinical Data Strategist at Thermo Fisher Scientific?

As an FSP Clinical Data Strategist at Thermo Fisher Scientific, you will primarily work in an office environment, collaborating with teams both in-person and remotely. The atmosphere is dynamic and engaging, with daily interactions with clients and colleagues. While most workdays will be within standard hours, there may be occasional travel needed, both domestically and internationally.

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Common Interview Questions for FSP Clinical Data Strategist
Can you describe your experience with clinical data management as an FSP Clinical Data Strategist?

When answering this question, highlight specific projects where you've taken the lead on data management tasks. Focus on your role in ensuring data accuracy and quality, the tools or methodologies you utilized, and how you collaborated with cross-functional teams to achieve successful outcomes.

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How do you prioritize tasks when working on multiple studies simultaneously?

Explain your organizational methods, such as using task management tools or prioritization techniques. Illustrate your ability to assess deadlines and significance of tasks while ensuring that all studies receive the attention they require to maintain quality and timeliness.

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How do you handle conflicts or discrepancies in clinical data?

Provide a structured approach for resolving conflicts in data. Discuss the importance of thorough investigation, collaboration with relevant stakeholders, and maintaining open communication to ensure that discrepancies are resolved quickly and effectively.

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What strategies do you use to mentor junior staff in clinical data review processes?

Discuss your approach to mentorship, emphasizing the importance of hands-on training, regular check-ins, and providing constructive feedback. Mention how you tailor your guidance based on the team member's experience and knowledge.

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What key performance indicators do you track to assess study data quality?

Identify several important KPIs, such as error rates, the pace of data entry, and timeliness of data review. Explain how monitoring these metrics helps you maintain high standards and contribute to successful clinical trial outcomes.

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Can you give an example of a successful risk management strategy you implemented?

Choose a specific example where you identified potential risks early and acted to mitigate them. Detail the steps you took, the collaborative efforts involved, and the positive outcomes as a result of your proactive planning.

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How do you approach team collaboration across different functional areas?

Elaborate on your communication strategies, such as regular meetings, use of project management tools, and fostering an open environment for feedback. Share examples of how effective collaboration has led to improved clinical data management.

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What analytical tools do you have experience with that support data review?

Discuss several analytical tools you've used in the past, mentioning specific functionalities that aided in data analysis and reporting. Emphasize your ability to quickly adapt to new technologies and your continuous desire to learn.

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How do you keep updated with regulatory guidelines in clinical data management?

Explain your commitment to professional development, such as attending workshops, reading industry-related publications, and participating in relevant forums or networks, ensuring you're always compliant with current regulations.

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What is your approach to developing training materials for new processes in clinical data review?

Outline how you assess the needs of the team when creating training materials. Discuss how you ensure that materials are comprehensive yet accessible, possibly incorporating visuals or interactive components to enhance learning.

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Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing ...

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Full-time, hybrid
DATE POSTED
March 29, 2025

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