Job Description

This is for a 6-month Co-op lasting from January - June 2022

Global Clinical Operations (GCO) is part of the Clinical Sciences organization within Research and Development (R&D).  GCO supports Clinical Sciences by providing expert operational delivery on our R&D clinical pipeline trials (phases 1-4).  GCO is a key member of the Project Team and leads the Clinical Study Management Teams.  We strive to be a world class organization that brings disease and phase aligned operational and scientific expertise to our pipeline studies.  A customer-focused mindset and delivering on quality & value are integral to how we conduct our business in GCO and are exhibited through our growing site and patient engagement activities.

How we do this is by developing the strategy for running clinical trials and execute on the strategy in partnership with multiple clinical trial vendors.  Clinical trials are complex and require extensive internal and external partnerships, and this is where this group has extensive expertise.  In addition, there are multiple regulations and good practices that we follow to ensure patient safety, data integrity and compliance through everything that we do.

The work we do provides choices to patients and their families, giving opportunities to participate in clinical trials, providing access to novel potential treatments and offering solutions for unmet needs.

POSITION DESCRIPTION

This role will be an integral part of newly generated Clinical Trial Accelerator Unit [CTAU] and/or the Clinical Trial Delivery Unit by providing key activities for study delivery and support. Assist in ensuring studies are executed in compliance with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs).

Examples of responsibilities may include:

Along with core team members, they will support the development, maintenance and update of a series of templates and documents, including but not limited to:

• Key process documents including RACIs and Gantt Charts
• Training documents including powerpoints and animations
• Templates to support deliverables e.g. feasibility outputs

Supporting key Operational activities including but not limited to:

• Identifying risks and supporting improvement efforts
• Partnering with third party vendors on key deliverables
• Troubleshooting and issue identification

Supporting Operational Quality efforts including but not limited to:

• Corrective and Preventative Action (CAPA) support and follow up
• Trial Master File (TMF) metrics tracking and coordination
• Inspection support and pre-inspection readiness activities

Partner closely with the pertinent Clinical Research Organization (CRO) team including but not limited to:

• Oversee operational aspects of study
• Identify and resolve project issues
• Support vendor management oversight
• PowerPoint generation ahead of Townhalls and functional meetings
• Designing and distributing functional newsletters and communications

Shared responsibility for periodic metrics generation & updates

• Using a range of tools from MS Excel to Business Intelligence Systems.
• From these metrics you will generate and socialize various analyses and outputs e.g. Study Start-up Cycle time assessments across Phase.

Opportunity to assist with Vendor Assessment & outreach activities as new and novel vendors are researched to accelerate our Clinical Trials, and, reviewed against our Portfolio needs. You will maintain oversight of industry events and conferences which may be of relevance to the CTAU and support with the generation of any associated resources required.

Qualifications

Although you will be well supported, from a day-to-day basis there will be an expectation to work independently and proactively. The role would suit someone with an analytical mindset and an appetite for innovation, technology and exploring novel approaches to clinical trial delivery.

To participate in the Biogen Internship Program, students must meet the following eligibility criteria:

• Legal authorization to work in the U.S.
• At least 18 years of age prior to the scheduled start date
• Be currently enrolled in an accredited college or university

EDUCATION

Bachelors or Masters degree students.

Additional Information

All your information will be kept confidential according to EEO guidelines.