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/Senior 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/Senior Manager working on the Clinical Data Solutions team, you will be empowered to provide timely and high quality data management deliverables supporting the Takeda Portfolio, and a typical day will include:
- 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, BEHAVIOURAL COMPETENCIES 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
- 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.