CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Associate Director, Clinical System Management? The job is located in the King of Prussia office or Marburg Germany. This is a hybrid position. You will report to the Director eClinical Operations.
Position Purpose:
You will manage the strategic leadership for all technology in Clinical Development Operations. You will work with all members of the Clinical Development Operations (CDO) to determine the technological needs of the department and serves as an interface with the R&D IT corporate position to ensure strategic understanding of global IT processes. We are looking for an in-depth knowledge of clinical development business processes and the technologies employed to allow them. You must lead global, teams including external service partners to identify. This important role will lead a team of Clinical System Managers and provide strategic leadership.
Main Responsibilities and Accountabilities:
- Lead a team of Clinical System Managers that oversees the eClinical Operations suite of solutions including the following: CTMS/eTMF (Veeva Clinical Vault), EDC (Medidata), RBQM, Site Feasibility systems, and Site Portals.
- Partner with IT and Clinical Development Business Process Owners, deliver the Clinical Development IT Systems Roadmap
- You will influence both the business and the IT interface for all systems that are used in Clinical Development Operations • You will stay current with Vendor Product Offerings and Allowing Technologies, proposing applicability of new or changing systems, and leading the implementation of large projects to deliver the applicable systems Clinical Development Operations business groups.
- Lead Clinical Development Change Management Programs necessitated by new and changing technology, including assessing impact and developing appropriate communications to ensure smooth transitions, accounting for all geographies and constraints.
- Provide Targeted Communications to the broader R&D organization to ensure understanding of Clinical Development technologies in use.
- Manage complex interactions with vendors, including on-boarding of vendor resources, oversight of vendor deliverable quality.
- Enforce vendor adherence to SOPs and related policies (i.e. ITQMS)
- Ensure delivery against statements of work and other contractual vendor agreements.
- Follow ITQMS and IT Processes, serve for Clinical Development for new systems and upgrades for clinical systems.
- Develop annual IT budget for Clinical Development and report project spending against budget.
- Help develop the processes and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality standards.
- Establish measurements for system support, and implement improvements based on performance data
Qualifications:
- Bachelor's degree in business administration, statistics, finance, or a related field (or equivalent work experience).
- Minimum 3 - 5 years of experience in clinical research or biotech industry or IT with profound knowledge of e-clinical systems specifically in CTMS/eTMF (Veeva Clinical Vault), EDC (Medidata), RBQM, Site Feasibility systems, and Site Portals.
- 2 years Leadership experience
- Project management skills, with experience managing system implementations.
BENEFITS
- Medical, Dental Vision
- 401K
- Paid time Off
Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
