Associate Director, Clinical Data Management

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Job Description

Objective / Purpose:

The Associate Director (AD), Clinical Data Management (CDM) is responsible for timely and high-quality CDM deliverables in support of Takeda global development programs, post-marketing registrational and non-registrational studies, providing support at the program, group of programs, and/or portfolio level.

The AD, CDM may be responsible for oversight of CDM activities conducted within Takeda or by strategic partners, CROs, or other third-party vendors; ensuring obligations are met as described in ICH-GCP, and Takeda’s Scope of Work.

The AD, CDM champions accelerating the adoption and effectiveness of CDM tools/technologies and are responsible for providing leadership and consultative expertise in initiatives, and for promoting operational efficiency and process excellence (e.g. regulatory submissions, inspections, lessons learned).

The AD, CDM provides subject matter expertise and enables solutions for complex problem-solving that aligns with the Takeda values. This role operates as a recognized expert with in-depth knowledge of the CDM discipline having broad impact on the business that affects operations within and across Therapeutic Area Units (TAU) and the department.

The AD, CDM may have direct line management responsibilities and/or supervisory responsibility of global Functional Service Providers (FSPs).

Accountabilities:

Responsibilities may include:

• Direct line management and/or mentoring and coaching to CDM team members: o Provides line management of direct report employees by establishing performance goals, providing ongoing mentoring, soliciting feedback from stakeholders and providing an open line of communication for feedback and support, including the delivery of performance reviews.

• Provides timely performance feedback to direct line managers for CDM staff assigned to projects.
• Supervises FSP staff, vendors, and contractors.

• Accountable for overall delivery of CDM deliverables and project execution:

• Provides oversight (or direct support as needed) of CDM activities for studies and programs conducted within Takeda, or by strategic partners, CROs, or other third-party vendors; ensuring obligations are met as described in ICH-GCP, and Takeda’s Scope of Work.
• Represents CDM function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all CDM related deliverables, especially in support of key decision points and regulatory submissions.
• Accountable for the achievement of major CDM deliverables and milestones in coordination with the cross-functional Study Execution Team (SET).
• Accountable for the planning and management of external CDM budgets (in collaboration with Clinical Operations TAU Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• Provides oversight into the quality and timely creation and maintenance of data collection tools (e.g. EDC, IRT, ePRO, eCOA), study data cleaning plan components, including edit checks, listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
• Ensures comprehensive and current data review is maintained during the study, including query management, and oversee/leads activities required for interim and final database locks.
• Ensures archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Participates in preparing function for submission/inspection readiness and may represent function in a formal inspection, audit, or regulatory interaction.

• Ensures adequate resources to support CDM activities:

• Accountable for securing and coordinating functional resources to support all studies within scope to ensure timely and quality delivery for the design and implementation of data capture tools, data processing, coding and validation.
• Leads and/or manages resources involved in clinical trial data collection set-up, data review, and database lock.
• Consults other ADs to allocate FSP resources as required to support study conduct and operational strategies; ensures FSPs have the appropriate tools, technology, and access to perform required duties.
• Accountable for functional resource coordination to ensure support for Submission Working Group activities as needed.

• Provides department level leadership:

• Leads and/or consults on continuous process improvement initiatives at the enterprise and departmental level in support of best practices and operational excellence; provides strategic direction and identifies key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Liaises with ADs across CDM to optimize and promote consistency of operations and excellence across TAUs.
• Serves as a subject matter expert and point of contact for staff supporting operational and oversight models.
• Apply expertise in the development and enhancement of new and existing tools, technologies, and processes within and across TAUs and the department; champions adoption and use in CDM processes.
• Anticipates internal and/or external business challenges and/or regulatory issues; recommends process, product or service improvements.
• Provides input to functional governance with Takeda's strategic suppliers. Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
• Maintains SOPs, process maps, templates, and timelines to support operational and oversight models.
• Prepares metrics to support the function's Key Performance Indicators (KPIs).
• 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.
• Ensures compliance with corporate and/or GXP requirements.

•Performs other duties as assigned.

Education & Competencies (Technical and Behavioral):

• Preferred 10 plus years clinical data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.

• Successful experience managing vendor relationships and alliance partnerships with at least 4 years’ experience in this area.

• Minimum 3 years of line management experience or equivalent.

• Experience with supervising staff augmentation (e.g. FSP).

• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.

• Experience with all phases of development in one or more therapeutic areas preferred.

• Ability to handle multiple development programs simultaneously.

• NDA/CTD Experience preferred.

• Expert knowledge of data management best practices, standards library development and maintenance.

• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

• Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Locations

Lodz, Poland

Base Salary Range:

zł272,200.00 - zł374,330.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time