Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Responsible for the Clinical Programming leadership, delivery and quality efforts in support of Clinical Data Sciences activities within the Clinical Development Operations organization.
Duties and Responsibilities:
• Leadership responsibilities for internal clinical programming and ad-hoc requests for Alkermes clinical programs from database start-up through database lock and CSR/submission.
• Manages clinical vendors and programming relationships specific to clinical programming/data review outputs, metrics and dashboards, data cleaning, ad-hoc reporting, data review, data surveillance and data mining via strategic partnerships with preferred vendors.
• Oversight of programming specifications, templates and documentation in accordance with ICH/GCP guidelines and current regulatory requirements.
• Provides support and consultation to Data Management in review of key documents such as data validation specifications and listing programs, User Acceptance Testing, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc.
• Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data or data cleaning/validation, safety signaling, clinical data review, etc., for internal clinical data review.
• Develops and implements clinical programming request tracking mechanisms. Tracks, analyzes, and reports on internal programming requests and clinical programming key performance indicators, metrics, and program level deliverables and timelines.
• Drives, supports and maintains appropriate Data Visualization tools providing information about data quality, study metrics, etc.
• Liaises with Technical Solutions group on initiatives including system integration, data transfer and sharing, access and storage. Leads and/or supports other initiatives to support Process or Technological Improvement, such as Clinical Data Review, Risk Based Monitoring, Data Standards, Coding and Lab review.
• Assists in development and maintenance of Clinical Standards templates including eCRFs, edit checks, table shells, clinical data archiving, etc.
• Collaborate with Clinical Data Analytics team to support a Clinical Data Lake environment.
• Contribute in all aspects of data strategy, analytics, visualization and adoption of a “Data Culture” within the organization.
• Science and/or Computer Systems/IT background, Bachelor’s or healthcare degree (i.e., Science, Programming or Technical discipline)
• Minimum 8-10 years (3-5 years supervisory/leadership) experience in a pharmaceutical/biotech setting preferred
• Advanced programming and analytical skills using BASE/SAS, SAS/STAT, SAS MACROS
• Advanced technical expertise in databases development, EDC experience in one or more of the following systems (OmniComm, TrialMaster, Medidata RAVE, Oracle Clinical, InForm, ClinTrial); data imports/integrations; SAS and/or SQL
• Knowledge and use of data visualization or data review tools (D3.js, Spotfire, Tableau).
• Programming\analytical skills using R and Python a plus.
• Excellent project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
• Demonstrated written and oral presentation skills and ability to communicate effectively to other programmers and non-technical colleagues
• Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
• Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
• Experience in leading cross-functional, multicultural and international clinical programming efforts/ teams.
Physical Demands and Work Environment:
• Travel domestic and international – up to 15%
• In-house position based in Waltham, MA
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.