Manager, Clinical Science Analytics & Insight - Clinical Trial Services
Location: Berlin Berlin Germany
Berlin Berlin Germany
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 81
Precision medicine is revolutionizing the charge on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials.
We offer remote based working options in Europe (including UK, France, Spain, Italy, Germany, Poland, Hungary, Netherlands, Belgium, Romania, Serbia)
- Serves as the functional lead (core team member) representing Clinical Science Analytical Insight / Operational Strategy (CSAI-OS) on assigned project team
- Lead all aspects of and supports the Clinical Science Analytical Insight / Operational Strategy (CSAI-OS) Scientists in the review of subject data for accuracy per protocol, associated references and oncology standards of care and principles.
- Coordinates and conducts targeted reviews and analyses of clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on the project specific review guidelines with an emphasis on scientific and clinical sense
- Serves as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
- Assesses routine status updates on findings and intensifies issues as appropriate with project team and CSAI-OS Management
- Supports the identification of quality risks and issues and recommends corrective action plans as needed to address deficiencies in performance throughout the life of the project
- Leads and/or conducts UAT of CSAI-OS programming output and participates in EDC UAT supporting the CSAI-OS functionality as applicable
- Provides review of the protocol from a scientific-operational perspective detailed understanding of assigned protocol and protocol requirements
- Provides indication specific input into data capture and other clinical trial document development (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
- Issues and resolves queries in various EDC systems when needed
- In particular you will be focused on early phase oncology clinical trials (ph I)
- From a scientific perspective, you will oversee team review of clinical data, by applying the protocol, other references and oncology standards, for the indication being studied.
- Support overall clinical data quality and consistency, allowing the for insights to support a continuous risk management approach.
- Have input into protocol and CRF design etc, from a scientific clinical review perspective, as required
- Develop and maintain strong working relationships with internal and external project team members
- Bachelor’s degree or equivalent combination of education/experience in science or healthcare field with proficiency in medical terminology.
- Strong line management experience in clinical operations, data management, safety or related field in either the CRO or pharmaceutical industry, with previous on-site monitoring experience and/or data review experience
- Oncology therapeutic experience required with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.)
- Supervisory experience executing process, people and/or teams
- Mastery level skill set in oncology clinical standards including the application of disease assessment criteria, standard of care, grading criteria, etc.
- Experience with electronic data capture systems (EDC) and data visualization tools
- Strong understanding of FDA & ICH/GCP regulations and guidelines
- Experience as a Clinical Research Associate (CRA) preferred. This role could suit a CRA or clinical professional who is particularly interested in the clinical science within Oncology.
- Experience in the review of data from oncology clinical trials with solid understanding of oncology standards (e.g., application of tumor response criteria, CTCAE criteria, etc.)
- Knowledgeable about the operation of data monitoring committees, dose review committees, and independent response adjudication committees, etc.
- Experience in phase I, II and III oncology (hematologic and/or non-hematologic tumors)
- Medical related degree, (eg. RN, OCN, RPH, PharmD, etc.)
We offer an excellent compensation package, value our company culture and career advancement opportunities. This position is 100% remote!
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.