Takeda Pharmaceuticals Associate Director, Process Excellence, Clinical Data Management - REMOTE in Helena, Montana
As the Associate Director, Process Excellent Clinical Data Management, you will be responsible for defining and executing the strategy for process and training for Clinical Data Management (CDM). You will ensure comprehensive and fit-for-purpose processes are in place for outsourced and in-house clinical data management activities. You will partner with the Director of CDM Operations, the Associate Director, CDM Compliance & Quality Innovations, the CDM Leadership Team and other cross-functional leaders to identify and prioritize critical CDM processes for definition, improvement, and training development.
Contributes to the design and maintenance of a framework for CDM process & training implementation and management.
Liaises with other functional leaders on process and training for operational and oversight models.
May have accountabilities in one or in all of the below sets of accountabilities.
May manage staff who have the below accountabilities.
Process Definition, Implementation and Maintenance
Responsible for leading CDM process initiatives, including process definition, implementation, change management & training plans.
Defines project plans for initiatives and leads CDM and cross functional colleagues to ensure adherence to timelines for project completion.
Coordinates CDM Subject Matter Expert (SME) network for process topics to ensure timely discussion and update of processes as needed.
May serve as point of contact/SME for CDM staff for key topics such as database build, standards, data management plan, database lock.
Liaises with Clinical Research Organizations (CROs) at an operational level to ensure optimization around CRO process implementation and governance, and Takeda CDM oversight.
Develops expertise in how CDM processes are handled at Takeda for outsourced and in-house studies (e.g., processes/topics such as database build, CDISC and Takeda database build standards, data validation plan, external data transfer management, medical coding, SAE reconciliation, etc.). Along with department/function SMEs, serve as process point of contact for CDM and other functions’ staff.
Acts as a process expert for operational and oversight models.
May serve as primary point of contact for CDM procedural documents (i.e., policies, standards, Standard Operating Procedures (SOPs), or guidelines). Maintains these documents to support operational and oversight models.
Training Definition and Training Matrix Management
For new or revised processes, collaborates with functional SMEs to create and deliver overviews and training for CDM.
Defines project plans for training projects/deliverables and leads CDM and cross functional colleagues to ensure adherence to timelines for project completion.
Provides periodic communications to CDM staff on training updates, changes, and initiatives.
Collaborates within CDM and cross-functionally to build and own functional learning plans for all CDM staff, including job- or role-specific training that meets regulatory, corporate, functional, and learner requirements.
Drives training decisions on all CDM roles, ensuring everyone has a clear role assigned in the Learning Management System (LMS) and an associated learning plan.
Owns and approves any changes to the functional learning plans, including any R&D (or lower level), Global Compliance, or other global/enterprise training that may need to be incorporated.
Monitors functional training compliance reports and reviews/discusses with appropriate level(s) of functional leadership to ensure optimal completion rates with mandatory or key training.
May oversee vendors and consultants engaged to create and implement training materials.
Collaborates with CDM Compliance and Quality Innovations to determine processes to undergo quality assessment, and to incorporate findings from quality assessments in order to continually improve CDM processes.
Collaborates with Takeda GCP Process Excellence, Compliance and Inspection on process and training activities and initiatives.
Contributes to R&D continuous improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
Champions and adopts technology improvements and tools for use in CDM processes.
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 own Learning Curricula, corporate and/or GXP requirements.
Performs other duties as assigned.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA required preferably in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience.
Preferred 8 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
Preferred 3 years of line management experience or equivalent.
Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
Experience with all phases of drug development in one or more therapeutic areas preferred.
Ability to handle multiple projects/priorities simultaneously.
NDA/CTD experience preferred.
Expert 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.
Advanced knowledge of office software (Microsoft Office).
Experience with project planning & management.
Strong knowledge of relational databases and experience using multiple clinical data management systems.
Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
Experience adhering to functional budget and providing timely updates to manager regarding additional, potential spend or cost savings.
Strong knowledge of CDISC standards, SDTM and/or TA-specific standards preferred. Experience developing internal data standards and mapping of medical concepts is ideal.
Advanced knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology, and nature of disease processes.
Experience with process mapping, change management, training development preferred but not required.
Instructional design experience preferred but not required.
Base Salary Range: $160-190K, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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