Associate Director, Clinical Programming

4 weeks ago


Watertown, United States Alkermes Full time

Position Summary:

Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.

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

#LI-HB1

PDN-9bf18a53-b6f9-4f7b-bd27-a8501ca77306

  • Watertown, United States Gables Search Group Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex...


  • Watertown, United States Actalent Full time

    Job Title: Associate Director, Clinical Data ManagementJob DescriptionWe are seeking an experienced Associate Director of Clinical Data Management to define and lead our data management strategy. Reporting to the Senior Director, this pivotal role will oversee the start-up and execution of multiple, complex trials in collaboration with a Contract Research...


  • Watertown, United States Ventus Therapeutics Full time

    About us: Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and develop...

  • Clinical Director

    1 month ago


    Watertown, United States Atrius Health Full time

    SUMMARY Under general direction, the Clinical Director partners with a designated Service Line Chair and Executive Director(s) - Service Line to assure the execution of Atrius Health’s strategy and goals at an organization-wide specialty level. Supervises and manages Clinical Nurse Managers in a designated service line and collaborates with Practice...


  • Watertown, United States Actalent Full time

    Job Title: Associate Director, Clinical Data ManagementJob Description We are seeking an experienced Associate Director of Clinical Data Management to define and lead our data management strategy. Reporting to the Senior Director, this pivotal role will oversee the start-up and execution of multiple, complex trials in collaboration with a Contract Research...


  • Watertown, United States Maplewood at Weston Full time

    Assisted Living Director (Clinical Care Coordinator) Maplewood Senior Living is seeking Assisting Living Directors to join their team. As an Assisted Living Director, you will play a vital role in overseeing recruitment, onboarding, and supervision of care associates. Your responsibilities will include ensuring all care tasks are monitored, schedules are...


  • Watertown, United States Planet Pharma Full time

    LOCAL CANDIDATES ONLY, PLEASE. This position will be hybrid in Waltham, MA - 3 days per week onsite. Open to AD to Director level. This is a direct-hire (permanent) role with our client, a Biotech sponsor company. This will be the first person in the TMF department and will drive TMF strategy, processes, vendor management and Inspection readiness. ...


  • Watertown, United States INSTITUTE FOR HEALTH Full time

    Job DescriptionJob DescriptionJob Title: Director of Family Engagement ProgramsProgram/Department: Family and Children’s ServicesPosition Type: Full-Time 40 hours/ week – Hybrid Position (remote and on-site)Location: Watertown Reports to: Executive Director The Institute for Health and Recovery (IHR) is a statewide service, research, policy, program...


  • Watertown, United States Q32 Bio Inc. Full time

    General Scope and Summary Q32 Bio is searching for an experienced professional to join our team as an Associate Director, Accounting (Associate Director). Our new Associate Director will be responsible for all aspects of the monthly and quarterly financial close, assisting with SOX compliance and supporting the SEC reporting process. The Associate Director...


  • Watertown, United States Corrona Full time

    Summary of Position: The Associate Director of Epidemiology and Outcomes Research (ADEOR) will be involved in managing the day to day activities of the Clinical Research Managers across the registries. Critical skills for this position include understanding the research process, ability to develop abstracts/manuscripts/presentations, experience in project...


  • Watertown, United States GlaxoSmithKline, plc Full time

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the cours Director, Support, Associate, Operations, Clinical Research, Excel


  • Watertown, United States C4 Therapeutics Inc Full time

    Job DescriptionJob DescriptionAbout C4 Therapeutics:C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is leveraging its TORPEDO® platform to efficiently design and...


  • Watertown, United States C4 Therapeutics Inc Full time

    Job DescriptionJob DescriptionAbout C4 Therapeutics:C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is leveraging its TORPEDO® platform to efficiently design and...


  • Watertown, United States Acrivon Therapeutics Full time

    Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is...


  • Watertown, United States Acrivon Therapeutics Full time

    Job DescriptionJob DescriptionSalary: Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision...


  • Watertown, Massachusetts, United States Acrivon Therapeutics Full time

    Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon's proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is...


  • Watertown, United States Seismic Therapeutic Inc Full time

    If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Associate Director of Finance Full Time Employee Management Watertown, Watertown, MA, US 12 days ago Requisition ID: 1045 About Seismic Therapeutic: Seismic, a biotechnology company, is determined to...


  • Watertown, United States Alkermes Full time

    Job Description Senior Manager/Associate Director, Sales & Marketing Analytics The Senior Manager/Associate Director, Sales & Marketing Analytics, is key member of the team providing analytical support to the Sales & Marketing function (Brand Marketing, Field Sales Leadership) of a growing commercial organization with three approved products and a portfolio...


  • Watertown, United States Beacon Hill Full time

    Title: CTA Location: Waltham, MA Hybrid (3 days in the office a week is a must have) Pay Rate: Open W2 Position Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in...


  • Watertown, United States ESR Healthcare Full time

    Emergency Department Director Watertown WI 53098 Job Type :Direct Hours :Full Time Required Education :Associates Degree Travel :No Relocation :No Job Industry :Healthcare - Health Services Job Category :Healthcare - Other Job Description : Description POSITION SUMMARY The Director, Emergency/Trauma Service (Director), under the general direction of the...