Site Relationship Manager, Value Based Medicine - United States
|External Posting Title||Site Relationship Manager, Value Based Medicine|
|Job Description||The Site Relationship Manager (SRM) within Value Based Medicine (VBM) will be responsible for the overall US site management, training and quality oversight of assigned studies. These studies will explore new technologies to generate, collect and present patient data seamlessly within the clinical practice setting. The goal of the studies is to explore innovative ways to learn from clinical practice and generate insights that can be used to inform decision making at the point of care. The SRM will execute site management and provide oversight of site training and quality in accordance with Biogen SOPs/processes. This position will also take on additional project management responsibilities as delegated by the Clinical Operations Lead. This position will report into the Project’s Director within VBM. It is strongly preferred that the SRM will be based within the Cambridge area to commute to the Biogen Cambridge office on a regular basis. This role requires an individual with demonstrable clinical operations experience and proven expertise in customer service. |
• Conducts Site Visits to orient and train site personnel regarding the protocol, study activities and applicable regulatory requirements.
• Assures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations Critically reviews and analyzes site activities and study conduct through on-site and remote assessments/contacts.
• Ensures timely submission of high quality of data from study sites and appropriate query resolution
• Ensures safety and protection of study subjects according to the monitoring plan, and applicable Biogen SOPs, and ICH GCP Guidelines and/or FDA/local regulations.
• Proactively works with sites to resolve issues, answer questions, and manage requests for study supplies.
• Interacts and builds professional and collaborative relationships with all study personnel and Biogen personnel in order to facilitate meeting study objectives.
• Takes on aspects of the project management as delegated by the sponsor, including development of study reports and trackers, quality metrics and risks and mitigations.
• Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.
• Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
• Proactively communicates and escalates with all internal and external stakeholders issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites including site specific ICFs and essential documents.
• Uses multiple technologies to foster, maintain, and enhance open communication
• Train, mentor and maintain oversight responsibilities of additional Site Relationship Manager(s) assigned to the studies.
• Communicates and provides oversight of specified vendors for quality and compliance. Performs on-site visits with specified vendors as applicable.
|Location||Cambridge, MA, US|
|Job Category||Global Medical/Medical Affairs|
• Minimum of 7+ years of clinical research experience with minimum of 5+ years of CRO/sponsor monitoring.
• Flexibility in travel to sites as needed. Expected to be on average 50% of time based on project needs.
• Strong customer service and relationship building skills with sites (on site and remote)
• Strong Site Management and Project Management skills including risk assessment and contingency planning
• Demonstrate a high degree of learning agility
• Possess a combination of critical thinking and operational know-how and efficiency
• Demonstrated success in working independently
• Strong communication and leadership skills
• Strong preference for candidate local to the Biogen Cambridge office to work on campus routinely
• Strong preference for experience with late phase and observational clinical research
• CNS and MS experience preferred
|Education||Minimum of a Bachelor of Science degree in a health related field with clinical research experience|
|About Biogen||Corporate Overview|
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
Biogen is revolutionizing biologics manufacturing, developing the industry’s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.
Our Corporate Citizenship
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.
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.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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