Senior Manager, Clinical Data Management, Rare Genetics and Hematology

Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 14, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakedaTakeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases - and vaccines. Boston (Massachusetts) is the R&D headquarters.REMOTE OPPORTUNITYSenior Manager, Clinical Data Management- Rare Genetics and HematologyAs the Senior Manager Clinical Data Management, you will be responsible for timely and high quality data management deliverables supporting the Takeda portfolio. - You will report to the Director, Clinical Data management and you 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.You will provide and enable solutions for complex problem solving that align with the Takeda values. - You will establish Project or Program level strategies and services, and are responsible for the management of vendor partnerships to maximize effectiveness and maintain budgets.You will serve as an expert for clinical data management, whether directly or by way of managing or mentoring other [junior] CDS 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. - Represent 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.
• Contribute influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Provide input to functional governance with Takeda's strategic suppliers. - Partner with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.Educational Qualifications
  • BS/BA required preferably in a health-related, life science area or technology-related fields.Experience
    • Minimum 6 years' or equivalence experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
    • 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.
    • NDA/CTD Experience preferred
    • Experience with data management best practices & technologies as applied to clinical trials.
    • Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
    • Experience with FDA and ICH regulations and industry standards applicable to data capture and data management process.
    • Experience with broad drug development process with expertise in the cross-functional interfaces with the data management function.Location: Cambridge - VirtualBase 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 excludedThis posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seqAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.EEO StatementTakeda 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.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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