Cambridge, MA
Live, first seen by us 83 days agoJob Level: Management Additional Information The base compensation range for this role is: $117,000.00-$157,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.Read the full posting
As a Data Manager in the Implantable Device Unit, you will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies. You'll act as the primary internal point of contact for data management operations, coordinating with both internal functions and external partners. Your responsibilities will include contributing to the development and maintenance of study data management plans, ensuring activities align with protocols, timelines, quality expectations, and regulatory requirements. By generating data listings, reports, and summaries using appropriate programming and data analysis tools, you'll aid study monitoring and internal decision-making. Additionally, you'll fulfill ad hoc data requests, resolve data issues, and collaborate with cross-functional stakeholders to support data quality and study results interpretation. This position is vital for providing leadership and hands-on support for effective study data oversight and CRO performance. This is a hybrid role to be based at our Headquarters in Cambridge, MA. What You’ll Do:Read the full posting
Employment type in the employer’s posting: Full timeFrom the employer’s posting
As a Data Manager in the Implantable Device Unit, you will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies.
This is a hybrid role to be based at our Headquarters in Cambridge, MA.
Oversee CRO data management deliverables, timelines and issue resolution
Generate clinical data reports, listings and summaries with programming tools
Prepare ad hoc analyses and outputs for internal stakeholders
Monitor data quality and coordinate needed database revisions
Coordinate data cleaning and query management with external vendors
As a Data Manager in the Implantable Device Unit, you will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies. You'll act as the primary internal point of contact for data management operations, coordinating with both internal functions and external partners. Your responsibilities will include contributing to the development and maintenance of study data management plans, ensuring activities align with protocols, timelines, quality expectations, and regulatory requirements. By generating data listings, reports, and summaries using appropriate programming and data analysis tools, you'll aid study monitoring and internal decision-making. Additionally, you'll fulfill ad hoc data requests, resolve data issues, and collaborate with cross-functional stakeholders to support data quality and study results interpretation. This position is vital for providing leadership and hands-on support for effective study data oversight and CRO performance.
This is a hybrid role to be based at our Headquarters in Cambridge, MA.
Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues
Generate clinical data reports, listings, and summaries using programming tools
Fulfill internal data requests by preparing ad hoc analyses and targeted outputs for stakeholders across various functions.
Monitor data quality and database readiness by identifying issues and coordinating needed revisions.
Coordinate data cleaning priorities and query management with external vendors.
Bachelor’s degree with at least 5 years of experience in clinical data management or related fields.
Proficiency in generating data outputs using SAS, Python, and advanced Excel tools (Power Query and/or similar tools).
Experience in oversight of CRO data management activities.
Excellent communication and collaboration abilities.
Experience with implantable devices and Class III medical device studies.
80 hours of sick time per calendar year
401(k) program participation with company matched contributions
Familiarity with regulatory submissions and protocol amendments.
Required Skills: - Bachelor’s degree with at least 5 years of experience in clinical data management or related fields. - Proficiency in generating data outputs using SAS, Python, and advanced Excel tools (Power Query and/or similar tools).
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- Bachelor’s degree with at least 5 years of experience in clinical data management or related fields. - Proficiency in generating data outputs using SAS, Python, and advanced Excel tools (Power Query and/or similar tools). - Experience in oversight of CRO data management activities.
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We file this job under Data Governance, by the work the posting describes.
Data governance staff keep a company's data accurate, documented and used within the rules. They agree what key fields mean, set up quality checks, track who owns each dataset and look after master data.
Postings ask for SQL, a governance tool such as Collibra or Informatica, knowledge of privacy and data rules, and a lot of work with other teams.
A data engineer builds the systems that move data; governance staff set and check the standards that data has to meet.
About This Role:
As a Data Manager in the Implantable Device Unit, you will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies. You'll act as the primary internal point of contact for data management operations, coordinating with both internal functions and external partners. Your responsibilities will include contributing to the development and maintenance of study data management plans, ensuring activities align with protocols, timelines, quality expectations, and regulatory requirements. By generating data listings, reports, and summaries using appropriate programming and data analysis tools, you'll aid study monitoring and internal decision-making. Additionally, you'll fulfill ad hoc data requests, resolve data issues, and collaborate with cross-functional stakeholders to support data quality and study results interpretation. This position is vital for providing leadership and hands-on support for effective study data oversight and CRO performance.
This is a hybrid role to be based at our Headquarters in Cambridge, MA.
What You’ll Do:
Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues to ensure alignment with study requirements.
Generate clinical data reports, listings, and summaries using programming tools to support study monitoring and decision-making.
Fulfill internal data requests by preparing ad hoc analyses and targeted outputs for stakeholders across various functions.
Monitor data quality and database readiness by identifying issues and coordinating needed revisions.
Partner with cross-functional stakeholders on data-related deliverables and issue resolution.
Collaborate on study data strategy, data review priorities, and CRO oversight.
Coordinate data cleaning priorities and query management with external vendors.
Partner on protocol deviation assessment and documentation quality.
Support resolution of quality issues affecting compliance or data integrity.
Provide data outputs and analyses for regulatory submissions and safety reviews.
Review study progress and operational issues impacting data quality and interpretation.
Who You Are:
You are a detail-oriented individual with a passion for data management and problem-solving. Your analytical mindset helps you effectively oversee complex data operations and collaborate with diverse teams. With a proactive approach, you thrive in fast-paced environments, balancing multiple priorities and deadlines. Your communication skills enable you to coordinate effectively with stakeholders and external partners. Above all, you are committed to ensuring data quality and integrity, contributing valuable insights for study success.
Required Skills:
Bachelor’s degree with at least 5 years of experience in clinical data management or related fields.
Proficiency in generating data outputs using SAS, Python, and advanced Excel tools (Power Query and/or similar tools).
Experience in oversight of CRO data management activities.
Strong analytical and problem-solving skills.
Excellent communication and collaboration abilities.
Preferred Skills:
Advanced degree
Experience with implantable devices and Class III medical device studies.
Familiarity with regulatory submissions and protocol amendments.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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Job Level: Management Additional Information The base compensation range for this role is: $117,000.00-$157,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Cambridge, MA
As a Data Manager in the Implantable Device Unit, you will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies. You'll act as the primary internal point of contact for data management operations, coordinating with both internal functions and external partners. Your responsibilities will include contributing to the development and maintenance of study data management plans, ensuring activities align with protocols, timelines, quality expectations, and regulatory requirements. By generating data listings, reports, and summaries using appropriate programming and data analysis tools, you'll aid study monitoring and internal decision-making. Additionally, you'll fulfill ad hoc data requests, resolve data issues, and collaborate with cross-functional stakeholders to support data quality and study results interpretation. This position is vital for providing leadership and hands-on support for effective study data oversight and CRO performance. This is a hybrid role to be based at our Headquarters in Cambridge, MA. What You’ll Do:
No clear work-authorization passage found. Eligibility is unconfirmed.