Sr Manager, Case Mgmt, Clinical Trial Safety

About This Role

The Sr Manager Case Management, Clinical Trial Safety will be responsible for managing the in-house case processing of clinical trial safety reports (and some post-market reports) in Biogen’s safety database. This role includes hands-on case processing and QC of ICSRs, workflow management, quality management, responsibility for the SMP and team line management. The Sr Manager will ensure consistent, on time and high-quality output of clinical trial ICSRs, working with cross-functional stakeholders. The Sr Manager will report to the Director of Clinical Trial Safety Operations within the Global Case Management function of Safety & Regulatory Operations, Medical Writing and Benefit Risk Management (SABR).

What You’ll Do

Overall case management activities for clinical trial ICSRs

Author and maintain the SMP

Perform data entry and in-line QC as well as retrospective QC

Liaise with ICSR Medical Evaluation team to solicit quality feedback and implement improvements

Oversee case workflow

Review and resolution of clinical/safety database reconciliation

Oversee clinical trial queries to sites/Investigators, escalating as required

Manage late case investigations for late regulatory reporting

Manage translations of source documents via vendor

Collaborate with TMF Operations and Clinical Safety Operations

Management of unblind accounts for CT ICSR SUSAR reporting

Who You Are

You are a seasoned case processor with a passion for quality and compliance. You have successfully managed case processing teams with high quality ICSRs and on time regulatory submissions. You are agile and decisive and will take initiative to use data to drive proposals for process improvements or quality initiatives.

Required Skills

BS degree in science or healthcare

7+ years of relevant PV experience, including clinical trial experience

Direct line management and/or case processing team management

Knowledge of global and local safety regulations

Excellent written and verbal communication skills

Excellent project management skills

Must be effective and collaborative in a fast-paced and matrixed environment

Effective managerial skills

Strong decision making skills

Job Level: Management

Additional Information

The base compensation range for this role is: $141,000.00-$188,000.00

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.

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.