Join us as an Associate Director of Clinical Data Solutions in our Cambridge office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
As an Associate Director working on the Clinical Data Solutions team, a typical day will include: OBJECTIVES: Responsible for ensuring timeliness and high quality for all Data Management (DM) deliverables globally within a therapeutic area.
Provides oversight of DM budget in collaboration with program management.
Provides data management expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.Contributes to management of strategic vendor partnerships in order to maximize effectiveness and efficiency of external (CRO) resources.ACCOUNTABILITIES: Responsible for vendor oversight activities across all global development programs within atherapeutic area.
Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.Provides input to functional governance with Takeda’s strategic suppliers.
Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics:Design and implementation of data capture toolsData processing, coding and validationResponsible for the quality of the data in each database, as well as quality of other data management deliverables Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documentsOversees the planning and management of external Data Management budgets (in collaboration with Clinical Operations TA Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc.
to identify industry best practice and increase the visibility of Takeda.Other duties as assignedEDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:BS degree in analytical or health-related field.10 years of data management experience in the pharmaceutical industrySuccessful experience managing vendor relationships and alliance partnerships with at least 4 years experience in this area3 years of line management experience.Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.Experience with budget planningStrong knowledge of relational databases and experience using multiple clinical data management systemsStrong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to ShineLearn more at takedajobs.com.No Phone Calls or Recruiters Please.LI-TRLLocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeFull time