Clinical Trial Manager Position at MorphoSys

1 post / 0 new
test1242
test1242's picture
Clinical Trial Manager Position at MorphoSys

MorphoSys – Engineering the Medicines of Tomorrow

As one of the leading public biotech companies in Europe, we are committed to developing the medicines of the future. Building on our portfolio of innovative antibody technologies, we are actively pursuing new therapeutic approaches in close collaboration with the world‘s foremost pharmaceutical companies and, increasingly, under our own initiative. To support our fast-track business and research activities, we have established a strong international presence through subsidiaries in the United Kingdom and the US. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Martinsried near Munich!

Clinical Trial Manager

– Reference number 45-1302 CMT-0212-JV -

Responsibilities

• Plan, implement and supervise clinical trials, working in close collaboration
with project leaders, clinical research physicians and other stakeholders
• Support Clinical Operations Manager with regard to the supervision of a
clinical trial and assume responsibility for assigned task package
(quarterly budgeting, CRO management, attending site initiation meetings,
etc.)
• Participate in CRO management and surveillance of outsourced clinical
trials
• Assist in managing co-monitoring activities for assigned trials
and participate in co-monitoring as needed
• Oversee execution of one or more clinical trials, while ensuring that all trial
deliverables are met according to specified timelines, budgets, resources,
etc.
• Contribute to preparation of clinical program documents (investigator
brochure, IND annual report, health authority briefing books and
submissions)
• Establish and manage study plan and ensure resolution of critical issues
• Identify areas of best practice and process improvement
• Develop study-related documents from concept sheets to final documents
• Define, negotiate and ensure execution of study-related agreements, such
as Clinical Trial Agreements, CROs, Central Lab Services, etc.
 
Requirements

• Minimum of three years’ professional experience in multinational clinical
trial management, focusing on the pharmaceutical or biotech industry
• Proven track record of compiling clinical study protocols, reports and
publications
• Demonstrable expertise relating to all aspects of the clinical development
process
• Ability to identify and resolve complex methodological issues relating to
clinical trials
• Well-developed organizational and interpersonal skills, complemented by
attention to detail
• Good knowledge of GCP and regulatory requirements (especially FDA and
EMEA)
• Finely honed written and verbal communication skills, underpinned by the
ability to present clear instructions/directions to teams within the
organization
• Willingness to travel (approx. 25%)
 
Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal http://www.morphosys.com/news-investors/careers/job-opportunities. We do not only offer excellent career prospects, but support you from the very start – also helping you move.
MorphoSys is an equal opportunity employer.

Deadline: Contact employer

For more details