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DOCS Senior Clinical Data Sciences Lead in Denver, Colorado

Senior Clinical Data Sciences Lead

Ref #: 27083

Employment type: Permanent - Full-Time

Location: US - Remote

Posted: 19-Feb-2021

Description

General:

• Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity

• Is recognized as an expert within the discipline and beyond, with peers within the same technical area in the business as well as other key business functions

• Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution

• Serves as best practice resource within own discipline or as technical expert on cross-functional teams or projects

• Has in-depth organizational and relevant market knowledge and uses understanding on how relevant areas can be integrated to achieve objectives.

• Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)

• Project management of all clinical data management related deliverables by ensuring adherence to planned time, cost and quality

• Execution of the clinical data collection strategy in accordance to Merck Standards (Data Collection, SDTM (CDISC)) as applicable

• Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s).

• Represents Data Management within the Global Trial Team and serves as the key Clinical Trial Execution point of contact for the DM related tasks in a trial/project/program

• Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams

• Drives and leads the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills

• Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines

• Accountable for partnering with CRO in DM related audit responses and addressing quality issues.

• Provides leadership and contributes to all operational aspects of the DM related trial budget, including forecasts to ensure delivery within the R&D financial standards

• Performs review and provides strong operational input in the development of Clinical Trial Protocols, Integrated Analyses Plan and CSRs

• Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges

• Supports the development and implementation of department initiatives including input on SOPs, processes, and work-streams

Senior Clinical Data Sciences Lead:

• Impacts as Program Data Manager projects/work streams with moderate complexity, risk, impact and reach. Impacts medium-sized global project teams with members also from outside the direct working environment. Coordinates stakeholders from closely related areas or even beyond

• Demonstrates skills in successfully leading international teams in the matrix organization and direct, influence and motivate people; contributes to a positive working climate

• Coordinates operational and therapeutic area training for internal and external study team members.

• Accountable for successful project execution including definition of milestones. May also include clarification of project scope. Receives minimal guidance or works independently. Acts as an advisor and mentor within the team and beyond and may serve as best practice resource within own discipline or as technical expert on cross functional teams or projects

• Serving as primary point of contact for any HA submission related activities (e.g. preparation of briefing books, attending HA meetings as requested)

• Leads the development of clinical data collection strategy in accordance to Merck Standards (Data Collection, SDTM (CDISC)) as applicable

• Initiates and leads process and technology improvement and re-engineering initiatives

• To represent the GCDS line management when requested

Strategic Impact

• Defines KPIs, Drives KPI improvement, Derives KPIs from project management tools and planning sheets

• Impact on delivery of submission relevant data to health authorities in Key Development projects

• Significantly contributes to a high priority project (NPV > EUR 800 m, expected peak year sales > EUR 700 m, yearly development costs EUR 25-100 m).

• Team member of the Clinical Operations Team and Program Team as applicable

• Defines and ensures Data Strategy, Data and Therapeutic Area Standardization across a complete Clinical Development program to ensure data pooling, successful submission management. Key role in contributing to fast decision-making in clinical programs.

• Initiates and leads process and technology improvement and re-engineering initiatives

• Defines KPIs, Drives KPI improvement, Derives KPIs from project management tools and planning sheets

• Budget Management

o Trial and project budget related to data management (multimillion EUR for large and complex trials)

o Budget of data sciences projects and other projects up to 5 Million EUR

Work Experience

• Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving

• Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 8 years

• Substantial project management experience

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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