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CSL Behring Clinical Study Manager, Early Development in Marburg, Germany

Clinical Study Manager, Early DevelopmentGermanyR-0921821010 CSL Behring GmbH (DE)

Job Description

The ED Clinical Study Manager CSM is responsible for/supports the on-time delivery of Early Development clinical study (studies). The CSM is responsible for/supports clinical operational planning activities and leading/supporting study execution of early stage clinical studies. The CPAT Senior SM/SM works closely with the Director ED Operations or ED Program Manager (PM) and leads/supports one or more global studies and may take on additional program responsibilities with oversight as required. The CSM leads/participates the Study Execution Team (SET) and oversees study level outsourcing and takes preventive/corrective action(s) to address study level issues. The CSM may be required to co-monitor as needed.

RESPONSIBILITIES AND ACCOUNTABILITIES

  • Execution of operational activities to ensure clinical study delivery

  • Act as the primary point of contact for internal groups outside of Early Development (Research, Regulatory, Bioanalytics , and Project Management) for study specific information

  • Maintain up to date knowledge of the Early Stage clinical studies, product candidate(s), clinical practice, competitors, and regulatory considerations

  • Ensure that IMPACT data is complete in a timely manner

  • Ensure standard processes, tools and procedures are used consistently for study execution

  • Support regulatory submissions, as required

  • Review country/site ICF

  • Support audits/inspections and resolution of findings

  • Support IMP management

  • Track contract execution and assist in resolution of site contract issues as required

  • Co-monitor as required

  • Clinical Project Management of an ED clinical program/study

  • Create and drive study level timeline

  • Develop overall feasibility concept and enrolment plan with appropriate input from internal stakeholders

  • Develop and manage study budget

  • Provide input on operational aspects of the protocol

  • Ensure regulatory compliance and Good Clinical Practice compliance

  • Responsible for oversight of Trial Master File with periodic audits

  • Responsible for/contribute to vendor selection and ongoing management (including issue escalation) and oversight of all outsourced activities

  • Develop and manage Study Management Plan and all associated documents (i.e. vendor oversight plan)

  • Collaborate with vendors and internal stakeholders to ensure that data is available for review by the Safety Review Committee in a timely manner

  • Collaborate with CS&L team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies. Plan, facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings

  • Ensure monitoring plan is developed and consistently executed in collaboration with appropriate stakeholders

  • Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and internal stakeholders

  • Assigns and documents study specific roles and responsibilities to internal and external team members

  • Consult with internal stakeholders for strategic selection of countries and sites

  • Facilitate and coordinate communications with external provider

  • Ensure Clinical Operations team and external partner receive study specific training

  • Report key study performance information, including study start-up metrics, enrolment, data collection timeliness/quality

  • Facilitate study close out activities through completion of Clinical Study Report

JOB SPECIFICATIONS

Education

  • At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).

  • Postgraduate qualifications highly desirable.

Experience

  • As a guide, a minimum 6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.

  • Experience in overseeing global clinical trials (pharmaceutical or research institute) is required.

  • A solid understanding of the drug development process, and specifically, each step within the clinical trial process. Prior experience in scientific/medical research advantageous.

  • Experience in Early Phase Clinical studies

  • Budget forecasting and management.

  • Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.

  • Ability to work independently with some oversight in the support and/or management of clinical trial execution.

Competencies

Communication and Interpersonal

  • Demonstrated ability to lead teams and work in a fast-paced team environment.

  • Experienced in working within cross-functional team in a Matrix Environment

  • Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Negotiation and influential skills advantageous.

  • Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.

  • Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.

  • Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.

  • Extensive and comprehensive knowledge of ICH guidelines/GCP, Maintains current medical/scientific/regulatory knowledge.

  • Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.

  • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.

  • Excellent written and oral communication skills.

  • Maintains computer literacy in appropriate software

Travel Requirements (Domestic, International, frequency)

  • Some degree of local, interstate and international travel required.

This is a full time position located at one of CSL’s site. A degree of remote/home working will be considered.

Share:

State/Province : Hesse

City : Marburg

Street Address : Emil-von-Behring-Straße 76

Primary Location : CSL Behring Marburg

Full Time/Part Time : Full Time

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

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