Data Manager

Biogen; Cambridge (MA); Ibrido; USD 117.000 - 157.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision, & Life insur.

401(k) with company match

Tuition reimbursement up to $10,000

Employee stock purchase plan

Paid vacation and holidays

Descrizione del lavoro

Biogen is seeking a Data Manager in the Implantable Device Unit to lead clinical data management for studies, coordinating with internal teams and external CROs. You will develop data management plans, ensure protocol alignment, and generate data listings and summaries to support monitoring and decision-making.

As a hybrid role based at our Cambridge, MA headquarters, you will drive data quality, oversee CRO activities, and support regulatory submissions with robust data analyses and reporting.

Competenze

• Bachelor's degree and at least 5 years of clinical data management experience.
• Proficiency in generating data outputs using SAS, Python, and advanced Excel tools (Power Query).
• Experience in oversight of CRO data management activities.
• Strong analytical and problem-solving abilities.
• Excellent communication and collaboration skills.

Mansioni

• Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues to align with study requirements.
• Generate clinical data reports, listings, and summaries using programming tools for study monitoring and decision-making.
• Fulfill internal data requests by preparing ad hoc analyses and targeted outputs for stakeholders across functions.
• Monitor data quality and database readiness by identifying issues and coordinating revisions with CROs.
• 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.
• Support protocol deviation assessment and documentation quality.
• Assist in regulatory submissions and safety reviews with data outputs.

Conoscenze

SAS

Python

Advanced Excel

Power Query

Formazione

Bachelor's degree in clinical data management or related field

Descrizione del lavoro

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.

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.

Benefits

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:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

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.