The Senior Clinical Data Operations Manager will be responsible for data processing and delivery operations with a primary focus on its central statistical surveillance platform, QDSS. This position will oversee the day-to-day data operations and collaborate with the Technology Group, Project Managers, Clinical Science and other staff to support client-facing delivery and operations activities. A demonstrated ability to distill clinical data into client-friendly deliverables is critical to success in this role. Preference will be given to candidates with experience that includes Risk-Based Monitoring at a CRO and/or data management responsibilities at a biopharmaceutical company.
- Our home office is in Wayland, MA, but our next hire may work remote. Applicants located on the east coast are preferred.
- MA/MS in Life Sciences, Computer Science, Statistics, or similar analytical field or a combination of education, skills and related experience.
- 5+ years of experience in Data Management, Statistical Programming, Quantitative Analysis, Analytics or related field
- Similar experience within the drug development domain is required. Must be able to analyze and interpret clinical (safety and efficacy) results
- Ability to analyze and interpret data, draw insights and prepare reports in a cohesive, intuitive and simplistic manner, adapting to the audience and business needs
- Experience managing delivery of data-based products to external customers is critical
- Experience in creating and implementing machine learning algorithms and advanced statistics to enable and expand existing data mining capabilities
- Must have proven project management experience including the development of project plans and the execution of those plans on time and within budget.
- Some experience with SQL querying and knowledge of PostgreSQL, MySQL and MSSQL databases
- Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
- Possess the ability to provide practical solutions to problems and situations ordinarily encountered in the role.
Preferred Qualifications & Experience:
- Experience with programming languages such as Perl, Python, Java, C++, SAS, Matlab and R preferred
- Experience in Statistical Process Control methods is a plus
Essential Duties / Responsibilities:
- Leads a matrixed team to coordinate and produce client-facing, project-related deliverables for the company’s scientific products, including its data analytics platform.
- Provide leadership in the delivery of services to customers.
- Ensure all work conducted is in adherence with GCP and Analgesic Solutions SOPs and lead remedial action if required.
- Drives operational excellence while fostering a culture of continuous improvement and accountability across all team members, regardless of reporting relationships.
- Leads and mentors project-assigned, highly skilled technical professionals in a matrix environment.
- Supports staffing needs, resource and project planning, deliverable management, training and career development.
Analgesic Solutions, LLC., a member of the WIRB-Copernicus Group, focuses on the reduction of risks in clinical trials through consulting, innovative tools, data science, technology and training. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for mitigating risk associated with measurement error in clinical trials, central statistical monitoring, and specialized training.
WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.