Clinical Data Strategist

Summarized Purpose

The Clinical Data Strategist (CDS) is accountable for tactical, detailed, high quality, and on-time data review deliverables.  The CDS acts as the lead subject matter expert and interdepartmental and client liaison for data review activities with focus on the development of study level analytic tools to detect, investigate, diagnose and mitigate issues and risk, set up oand development of functional plans and data review tools. 

A Day in the Life:

• Independently lead the development and implementation of results including data collection and data review tools, centralized statistical monitoring tools, data validation manual
• Ensures data reviews are completed on-time with more complex analyses or deeper root cause analyses to connect related signal to risk.  Leads high quality report development. 
• Leads data review meetings inclusive of reviewing trends, outliers, high risk sites
• Mentors junior level staff on all associated tasks within a study and delegates appropriate data reviews that match experience level.
• Assists with administrative oversight for allocated projects.
• Communicates with management regarding all activities within their studies.
• Investigates and contributes towards the development of innovative technologies to support all aspects of clinical delivery.

Job Complexity

Works on issues of diverse and complex scope where variable factors will require in-depth analysis, critical thinking, risk assessment and management, problem solving and determination of correct action.

Job Knowledge

An experienced professional with full understanding of area of specialization.  Uses professional concepts and company objectives to resolve complex issues effectively.

Business Relationships

Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations and requires coordination between functional areas.   Creates formal networks with key contacts outside own area of expertise

Education and Experience

Bachelor's degree or equivalent and relevant formal academic / vocational qualification previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Prior experience in clinical monitoring, centralized monitoring, data management, biostatistics or related field in support of clinical trials is preferred. 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.

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, motivate 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
• Strong oral and written communication skills (English)
• 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
• Acting as a subject matter expert and lead on projects cross-functionally, including delegating and effectively prioritizing individual and team workload

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.