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Senior Clinical Study Manager

King of Prussia, PA

Posted: 05/22/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2337

Our client is looking to add a Senior Clinical Study Manager (Senior CSM) to their team on a contract basis. Length of contract: 2 years. The person in this role will be responsible for clinical operational planning activities and leading study execution; usually of smaller, less-complex studies. The Senior CSM works closely with the Senior Clinical Program Manager (CPM) on a program or leads one or more studies and may take on additional responsibilities as dictated by study size and complexity (with oversight by Senior CPM or Therapeutic Area Clinical Operations Lead). S/he participates in or may lead the study execution team (SET), oversees study level outsourcing, and takes preventive/corrective action(s) to address study level issues.
  • This role reports to the Therapeutic Area Clinical Operations Lead or Senior CPM.
  • Direct reports: Clinical Trial Assistants (CTAs).
  • Matrix Environment: Interface with CPM, Lead Clinical Oversight Managers (LCOMs), Clinical Oversight Managers (COMs), Therapeutic Area Program Director and Clinical Scientist. Also interfaces with Clinical Supply and Logistics (CS&L), Core Project Team (Core Project Manager), Regulatory, and Clinical Quality Assurance

RESPONSIBILITIES INCLUDE:
  • Clinical project management of a clinical study
    • Create and drive study level timeline
    • Develop overall feasibility concept and enrollment plan with input from COMs
    • Develop and manage study budget
    • Provide input on operational aspects of the protocol
    • Ensure regulatory compliance and GCP compliance
    • Responsible for oversight of TMF with periodic audits
    • Responsible for/contribute to vendor selection and management including issue escalation
    • Develop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)
    • Collaborate with CS&L team to plan and coordinate IMP and non-IMP supplies
    • Plan, facilitate and lead SET internal meetings as well as act as the lead for vendor meetings
    • Ensure monitoring plan is developed and consistently executed in collaboration with COMs
    • Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
    • Assigns and documents study specific roles and responsibilities to internal and external team members
    • Consult with COMs 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, enrollment, data collection timeliness/quality
    • Facilitate study close out activities through completion of Clinical Study Report
  • Act as the primary point of contact for internal groups outside of CR&D (Regulatory, Commercial Development, and Project Management) for study specific information
  • 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
  • Domestic and international travel required. Amount dependent upon project needs

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).
  • Minimum 6+ 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 overseeing global clinical trials (pharmaceutical or research institute).
  • 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 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.

Desired Attributes:
  • Postgraduate qualifications.
  • Experience in scientific/medical research.
  • Specialist knowledge (e.g. immunology, coagulation disorders, pulmonology, virology, oncology, and cardiology).

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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