Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include:
- Responsible for timely and high quality data management deliverables supporting the Takeda portfolio.
- Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards.
- Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. Activities include from protocol synopsis through database release and submission
- Contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices.
- Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making.
- Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards.
- Participates in study level vendor oversight activities. May 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.
- Serves as a first point of contact for CROs partners when collaboration is needed 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.
- Acts as a process expert for operational and oversight models.
- Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
- May prepare metrics to support the function s KPIs.
- Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.
- Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documents
- Verifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting.
- Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Other duties as assigned
EDUCATION, EXPERIENCE AND SKILLS:
- BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience.
- 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 and at least 2 therapeutic areas.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience.
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
- Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
- Good understanding of CDISC standards, and experience implementing standards.
- Strong knowledge of clinical study reporting requirements including SAS programming.
- Advanced knowledge of office software (Microsoft Office).
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.
- Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
- Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
- Demonstrated strong matrix leadership and communication skills
- 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; challenge the status quo
- Pragmatic and support change
- Is comfortable with ambiguity
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to sit and stand for long periods of time.
- Carrying, handling and reaching for objects.
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.