Job DescriptionReporting to the Director, Data Analytics and Technical Solutions, this position is responsible for designing, maintaining and governing the Technical Solutions' clinical data ecosystem. This position will bridge the gap between complex clinical data sources and actionable business intelligence metrics utilized by Clinical Operations, Data Management and Clinical Programming departments within the Clinical Development Operations organization.
Responsibilities- Support the Clinical Operation data strategy / development initiatives including systems and technology integration, data collection and data storage into Alkermes Data Lake.
- Lead and/or support other clinical data technology-based data collection initiatives including but not limited to EDC, IxRS, and ePRO/eCOA.
- Responsible for developing Data Models, Data Flow and Data Governance & Standards processes utilizing industry standards like CDISC.
- Collaborate closely with the Data Analytic teams to build robust data models in Snowflake to support clinical analytics.
- Support CDO leaders and other functional leaders to ensure data collection effectiveness and efficiencies from systems and technology platforms.
- Collaborate closely with clinical development operations teams to triage Study or Program level data collection issues, risks and performance with business data collection processes, systems and/or technology.
- Support clinical data review, analytics and RBM solutions including data visualization and mining using contemporary or industry best practice tools.
- Champion efficient industry best practices; promote technical innovation.
Qualifications- Bachelor's degree in a scientific or technical discipline (e.g., Computer Science, Information Systems, Engineering, or related field) required; advanced degree (Master's or MBA) preferred.
- Demonstrated background in science and/or information technology, with a preference for candidates with a strong technical foundation.
- PMP certification or equivalent project management credential preferred.
- Minimum of 8 years of relevant experience, with prior experience in the pharmaceutical or biotechnology industry preferred.
- Advanced technical expertise in databases, EDC platforms, Snowflake, Tableau, data imports/integrations; Python, SQL and/or SAS programming.
- Experience supporting or driving data solutions projects or system implementation (i.e., data dashboards, data warehouse, data visualization and/or risk-based data review tools/systems) a plus.
- Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements.
- Demonstrated ability to collaborate effectively across cross-functional teams.
- Strong interpersonal, organizational, and prioritization skills, with the ability to manage multiple concurrent initiatives in a fast-paced environment.
- Proven analytical and problem-solving skills, with the ability to translate business needs into technical solutions.
- Ability to communicate complex technical concepts and data insights clearly to both technical and non-technical stakeholders.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $167,000 to $190,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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