Clinical Trial Manager

About This Role 

Biogens West Coast Hub based in South San Francisco is specifically focused on transforming the lives of patients with severe immunemediated diseases by developing novel targeted therapies with outsized clinical impact faster. To accomplish this we are seeking top talent to join us on our journey. 

As a Clinical Trial Manager you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies including operational design successful delivery and the positive impact on the lives of patients with a wide array of immunemediated diseases. This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis. 

What Youll Do 

• Independently or in conjunction with other study Clinical Trial Leads develop and oversee implementation of the studylevel operational strategy for the successful delivery of clinical studies. 

• Chair and CoChair the Clinical Study Team (CST) meeting to drive development of scientifically robust operationally feasible and clear concepts/protocols. 

• Provide operational guidance to sites CRO and other key suppliers 

• Provide operational oversight of clinical study suppliers 

• Strategize and coordinate efforts with study start up including sitefeasibility site selection and distribution of regulatory packets 

• Attend scientific meetings 

• Strategize and coordinate efforts to ensure completeness of eTMF 

• Oversee delivery of studies by CROs to ensure quality in line with time and budget forecasts. 

• Manage budget approve invoices and participate in the monthly accrual process 

• Participate in the testing of clinical study systems including IRT and EDC 

• Partner with the CRO SMT lead to ensure the CRO creates appropriate riskmitigation plans and effectively identifies/resolves issues. 

• Establish and drive efficient team operations by establishing an open culture defined by communication goal setting and oversight of strategy implementation. 

• Ensure effective consistent efficient and compliant processes. 

Who You Are 

Scientifically and clinically astute youre a missiondriven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than daytoday operations. Decisive analytical and selfconfident you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence. 

Qualifications :

Required Skills & Experience 

• Bachelors degree in a scientific discipline with 7 years of professional work experience in the life sciences 

• 5 years in clinical operations management overseeing outsourced clinical trials per quality timeline and budget expectations preferably with a sponsor company and a CRO 

• Related scientific and clinical expertise and exceptional projectmanagement riskassessment contingencyplanning and communication skills 

• Extensive knowledge of clinical development related to one or more trial phases (I II III or IV) as well as crossfunctional drug development 

• Unquestioned expertise in Good Clinical Practices (GCP) International Council for Harmonisation (ICH) guidelines and regulatory requirements for clinical development 

• Ability to establish operational plans and support the CRO in executing them 

• Effective CRO management skills and ability to adapt to the Global Clinical Operations (GCO) outsourcing model 

Preferred Experience 

• Sponsor and/or CRO Global trial management experience 

• Investigator site and/or monitoring experience 

Additional Information :

The base compensation range for this role is $. Base salary offered is determined though 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 longterm 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 wellbeing; including but not limited to:   

• Medical Dental Vision & Life insurances  

• Fitness & Wellness programs including a fitness reimbursement    

• Short and LongTerm Disability insurance   

• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31  

• Up to 12 company paid holidays 3 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 $10000 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 our DE&I efforts.

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 EVerify Employer in the United States.