Senior Manager, Clinical Data Management
Takeda · Warsaw · PLN 313,200–PLN 430,650 (stated in the posting)
Job Description
At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?
OBJECTIVES/PURPOSE
The Senior Manager Clinical Data Management is responsible for timely and high-quality data management deliverables supporting the Takeda portfolio. They are responsible for conducting oversight of Data Management activities at the project or program level as performed within Takeda or by Strategic Partners, CROs or other 3rd Party Vendors to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides and enables solutions for complex problem solving that align with the Takeda values. They establish Project or Program level strategies and services and are responsible for the management of vendor partnerships to maximize effectiveness and maintain budgets.
The Senior Manager Clinical Data Management serves as an expert for clinical data management, whether directly or by way of managing or mentoring other junior CDM Staff. They will lead cross-functional team members to perform proper Data Reviews and provides guidance on CDISC standards.
Key Accountabilities
- Responsible for leading data management activities for in-house and outsourced studies; may manage staff responsible for performing those activities.
- Responsible for vendor oversight activities across global development programs.
- 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.
- Contributes influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Provides input to functional governance with Takeda's strategic suppliers.
- Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensures achievement of major data management deliverables and milestones.
- Responsible for the planning and management of external Data Management budgets and timelines.
- Acts as a process expert for operational and oversight models.
- Maintains SOPs, process maps and templates.
- May prepare metrics to support the function’s KPIs.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc.
- Contributes or Leads functional Continuous Improvement initiatives.
- Works cross-functionally to ensure quality of data and on time delivery.
- Champions and adopts technology improvements and tools.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Performs other duties as assigned.
Educational Qualifications
- BS/BA required preferably in a health-related, life science area or technology-related fields.
Experience
- Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
- 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.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
Special Skills/Abilities
- Advanced knowledge of office software (Microsoft Office).
- Experience with budget planning & management.
- Strong knowledge of relational databases and experience using multiple clinical data management systems.
- Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry.
- Ensures adherence to functional budget.
- Expert knowledge of CDISC standards, SDTM preferred.
- Expert knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and disease processes.
Behavioral Competencies
- Pragmatic and willing to drive and support change.
- Is comfortable with ambiguity.
- Able to influence without authority.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
- Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
- Embody a culture of continual improvement and innovation; promote knowledge sharing.
- Demonstrated strong matrix leadership and communication skills.
Job Complexity
- Medium complexity projects, or platforms.
- Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.
Supervision
- Moderate supervision required should be able to function collaboratively (with some guidance) with all levels of employees.
Location
Warsaw, Poland
Base Salary Range:
zł 313,200.00 - zł 430,650.00
For information about our benefits, please click here.