Pieris Pharmaceuticals (Nasdaq: PIRS) is a publicly-traded, clinical-stage biotechnology company with operations in Germany and the United States. Pieris specializes in the discovery and development of Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. 

To strengthen our team, we are looking for an experienced

Clinical Data Manager (m/f/d)

Your Tasks:

  • Oversee all data management activities performed by CROs, from study start-up through database lock
  • Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol
  • Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing)
  • Lead development of data reports and facilitate cross-functional data review for assigned studies or programs
  • Define, generate, and analyze metrics across multiple studies, plan and execute risk mitigation strategies
  • Lead data review for accuracy, completeness, and consistency and perform QC as appropriate
  • Represent CDM at the cross-functional study team meetings, providing risk mitigation strategies and input based on best CDM practices
  • Adhere to study and program timelines and quality standards
  • Participate in process development
  • Develop data transfer agreements and specifications with various vendors
  • Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in conjunction with CRO(s)
  • Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any ad-hoc requests
  • Liaise with external vendors (Central Labs) in support of timelines and data related deliverables
  • Responsible for working with database build vendor to develop new EDC databases and subsequent revisions
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members
  • Monitor timelines and ensure that CRO clinical data management timelines are met with quality
  • Use industry standard conventions, tools, references and process in support of the coding of Medical History, Adverse Events and ConMeds/ConProcs

Our Requirements:

  • Bachelor’s degree, preferably in health science or related field and 5-8 years of industry experience
  • In-depth and breadth expertise in CDM and broad knowledge of Clinical Development, typically developed through extensive experience leading critical organizational initiatives
  • Proven record in CRO oversight activities
  • Recognized as a technical/professional expert and escalation pathway throughout CDO organization
  • Anticipate opportunities and problems and offer solutions and best practices
  • Proven track record of designing, leading and executing initiatives that have meaningful impact on critical goals
  • Contribute to the development of the CDM strategy as a subject matter expert
  • Strong project management and meeting facilitation skills
  • Demonstrated experience in writing professional correspondence and clinical study documentation
  • GCP knowledge
  • Strong EDC skills, including Medidata Rave
  • Strong understanding of clinical trial data
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem-solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions

We are a fast-growing biotechnology company with approximately 120 employees at our sites in Freising (Greater Munich Area) and Boston (USA). We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of individual and company-wide goals. In addition, we offer each employee the opportunity to participate in a stock savings plan and a stock option program that allows employees to benefit directly from the company's success.
 
Numerous social benefits such as additional employer-financed company health insurance, free drinks, fruit baskets etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment round off our overall package. Creative employee events take place several times a year, as team spirit is essential for us. The joint creation of an innovative and participative corporate culture is an important concern for us.