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Senior Manager, Clinical Data Solutions

Company: Takeda Pharmaceutical
Location: River Edge
Posted on: November 12, 2021

Job Description:

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Job Description
REMOTE OPPORTUNITY

Senior Manager, Clinical Data Solutions
As the Senior Manager Clinical Data Solutions, you will oversees and high-quality data management deliverables supporting the Takeda portfolio. You will report to the Director, Clinical Data Solutions of Neuroscience. You will conduct oversight of Data Management activities at the program level - as performed 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.

You will be an expert for clinical data management, whether directly or by way of mentoring other [junior] CDS Staff. You will lead team members to perform proper Data Reviews, and provide guidance on CDISC standards.

Key Accountabilities
Oversee vendor oversight activities across global development programs. Represent data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially to support essential decisions and regulatory submissions.
Contribute influential leadership in collaboration with other Takeda Partners to ensure established deliverables are met with the highest degree of quality.
Partner with appropriate team members and CRO partners to avoid and resolve risks.
Provide input to functional governance with Takeda's strategic suppliers. Partner with appropriate team members to resolves issues escalated from the vendor and teams.
Participate in preparing function for submission readiness and may represent function in a formal inspection or audit.
Represent function in formal inspections and audits.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
Ensure achievement of major data management deliverables with other departments including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
Manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Be a process expert for operational and oversight models.
Maintain SOPs, process maps and templates and timelines to support operational and oversight models.
May prepare metrics to support the function's Goals.
Represent function in external professional plans and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of Takeda.
Contribute and lead functional Continuous Improvement plans, providing strategic direction and identifying important deliverables that meet timelines, budget, and are with company, departmental requirements.
Ensure compliance with own Learning Curricula, corporate and GXP requirements.
Work to ensure the quality of the data in each database delivery, and quality of other data management deliverables

Educational Qualifications
BS/BA required preferably in a health-related, life science area or technology-related fields.

Experience
8 years data management and drug development process with expertise in the interfaces with the data management function.
Experience with project management managing data management activities for large drug development programs.
Experience with all phases of development in one or more therapeutic areas.
NDA/CTD Experience preferred.
Knowledge of data management best practices & technologies as applied to clinical trials.
Experience with 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.
Expert in Early Phase I Neuro studies preferred.

Special Skills
Experience with budget planning & management.
Knowledge of relational databases and experience using multiple clinical data management systems.
Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

Travel Requirements
Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.

Location: Cambridge - Virtual

Base Salary Range: $150,000-170,000 based on candidate professional experience level. Employee may also be eligible for Short Term and Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off. If candidate is not eligible for any benefits or other comp., those can be excluded
This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq

EEO Statement
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.

Locations
Boston, MA

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Tenafly , Senior Manager, Clinical Data Solutions, Healthcare , River Edge, New Jersey

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