Clinical Study Manager

Clinical Study Manager

Job Purpose

The CSM assists with clinical operational planning activities and support of study execution. The CSM works closely with the Senior Clinical Study Manager to support one or more studies and may take on additional program responsibilities with oversight by Clinical Program Manager(s) (CPMs) or Therapeutic Area Clinical Operations Lead. The CSM is part of a cross-functional team and helps to provide clinical program management and study execution at the global and/or regional level. The CSM may participate in the study execution team (SET) or other operational study groups, and may oversee selected study level outsourcing under CPM direction. The CSM may take preventive/corrective action(s) to address study level issues. The CSM may co-monitor as needed.

Main Responsibilities and Accountabilities: 

Responsible to execute and / or support the following activities to ensure study delivery:

• Clinical project management of a clinical study (studies) • Help to create and drive study level timeline • Assist with the collection of feasibility data to develop the enrollment • Assist with study budget issues, as assigned • Ensure regulatory compliance and GCP compliance • Responsible for oversight of TMF with periodic audits • Contribute to vendor selection and management including issue escalation • Support with developing and managing study plans (including but not limited to Study Management Plan, Vendor Oversight Plan, Compliance Plan, TMF plan) and all associated documents • May collaborate with CTS team to plan and coordinate IMP and non-IMP supplies • May lend support to SET internal meetings • Assist with development and execution of monitoring plan and monitoring oversight plan in collaboration with CPM and Site Management (COMs) • Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs • Consult with COMs for strategic selection of countries and sites • Help to ensure SET team and external partner(s) receive and document study specific training • May report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality • Facilitate study close out activities through completion of Clinical Study Report

• Co-monitor as needed

• Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations

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

• Ensure complete and timely IMPACT updates

• Support regulatory submissions

• Review country/site ICF

• Support audits/inspections and resolution of findings

• Track contract execution and assist in resolution of site issues in partnership with Site Management and COMs

• Support IMP management

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).

Experience

Essential Experience: • As a guide, a minimum 4+ years’ relevant clinical research (or related) experience within the pharmaceutical industry. • A solid understanding of the drug development process, and specifically, each step within the clinical trial process. • Experience in supporting the execution of global clinical trials (pharmaceutical or research institute). • Understanding of 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. Desired Attributes – The following are considered desirable: • Postgraduate qualifications. • Experience in scientific/medical research. • Specialist knowledge (e.g. immunology, coagulation disorders, pulmonology, virology, oncology, and cardiology). • Demonstrated proficiency in advanced MS Project.

Competencies & Skills

Demonstrated ability to lead teams and work in a fast-paced team environment. • Experienced in working within a Matrix Environment • Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. • 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.

CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability. CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.