Associate Director, Clinical Programming
Position Summary :
Leadership position responsible for Clinical Programming efforts in Data Management & Programming department and Clinical Development Operations organization.
Duties and Responsibilities :
- Leadership responsibilities for internal clinical programming, SDTM conversions and ad-hoc requests for Alkermes clinical programs from database start-up through database lock and CSR / submission.
- Manages clinical programming team specific to SDTM, 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, 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 for data cleaning / validation, SAS listings review, TLF, dry runs, etc.
- Develop and implement a programming request tracking systems. Track, analyze, and report on internal programming requests and clinical programming key performance indicators, metrics, and program level deliverables and timelines
- Drive the development of Data Visualization tools providing information about data quality, study metrics, etc.
- Liaise with Technical Solutions group on initiatives including system integration, data transfer and sharing, access and storage.
Lead and / or support other initiatives such as Data Review, Risk Based Monitoring, Data Standards, Coding and Lab review
- Contributes to project budget / resource planning, re-forecasting, program milestones, along with DM & Programming leadership
- Assists in development and maintenance of Clinical Standards templates including eCRFs, edit checks, table shells, clinical data archiving, etc.
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Experience in working in cross-functional, multicultural and international clinical trial teams.
Basic Requirements :
- Science and / or Computer Systems / IT background; MBA, advanced degree and / or PMP certification preferred
- Minimum 10 years (3 years supervisory / leadership) experience in a pharmaceutical / biotech setting preferred
Preferred Requirements :
- Advanced experience in programming tools such as SAS, R, PL / SQL, Perl, Python, etc.; technical expertise in databases, EDC platforms, data imports / integrations preferred.
- Knowledge of CDISC SDTM is a must.
- Advanced knowledge of GCP / ICH standards, 21 CFR Part 11, CDISC (SDTM, ADaM, SEND) requirements.
- Strong leadership skills and ability to work within cross-functional teams
- Excellent interpersonal, organizational, and multi-tasking skills
Physical Demands and Work Environment :
- Travel domestic and international up to 15%
- In-house position based in Waltham, MA
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