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Clinical Study Manager

King of Prussia, PA

Posted: 11/20/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2483

Job Description


The Clinical Study Manager (CSM) is responsible to support the on-time delivery of a clinical study (studies).  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.

Responsibilities:
  • 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

Requirements/Qualifications:
  • 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, experience in scientific/medical research, and specialist knowledge (e.g. immunology, coagulation disorders, pulmonology, virology, oncology, and cardiology) are all desired attributes.
  • 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.
  • Demonstrated proficiency in advanced MS Project.
  • 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.

Meet Your Recruiter

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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