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Sr. Manager, Clinical Development Compliance

Cambridge, MA 02142

Posted: 08/12/2019 Employment Type: Direct Hire Job Category: Clinical: Document Management Job Number: 2421

This newly created position reports into the Director, Clinical Development Compliance, SOPs, Disclosure within the Clinical Development Compliance & Operations Excellence Organization, and will provide subject matter support to facilitate optimal clinical development GCP compliance management oversight.

Primarily, this role will support study adherence to applicable GCP regulations; providing GCP guidance and subject matter compliance support to clinical development functions through all phases of clinical development internally and will:
  • Be recognized as a knowledgeable resource, subject matter support and primary point of Clinical compliance tracking.
  • Collaborate effectively with all functions to confirm adherence to good clinical practice (GCP) compliance execution through all stages of clinical trial conduct, including but not limited to: core document compliance, oversight support, internal audit support, critical issue escalation facilitation, and CAPA tracking

Primary Responsibilities Include:
  • Serve as Clinical Development Compliance support on identified trial teams; facilitating GCP compliance by aiding in the identification, assessment, escalation, and tracking of emerging and significant risk/issues of non-compliance    
  • Support compliance activities including SOP activity and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R2)
  • Support the Clinical Teams with the execution of identified CAPA responses and tracking
  • Assist Clinical Teams, as support, in all stages of Audits (i.e. audit preparation activities, notification, liaison activities, development and approval of effective responses).
  • Support inspection preparation activities as required
  • Track, trend, and escalate (as applicable) facilitating closure/evidence of completion of assigned Clinical Development corrective action commitments; confirm that all actions and commitments related to inspections are implemented in accordance to plan.
  • Support process build of clinical development process and business area SOPs as fit for purpose and in compliance with regulatory requirements; confirm SOPs are an accurate representation of the way work is executed
  • Provide input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on-going adherence to standards and regulations.
  • Assist with the creation and delivery of tools, templates, training, and guidance for best practice and reporting and minimizing risk while ensuring quality is integrated into our processes
  • Support the disclosure process by tracking disclosure activity and status and following process through to filing completion

Requirements / Qualifications: 
  • Bachelor’ s Degree is required. An advanced degree is highly preferred
  • 5+ years of experience gained with a CRO, biotech, or pharmaceutical company
  • 5+ years of compliance, GCP Function, or clinical project support
  • Experienced in supporting clinical trial GCP compliance/quality management activities
  • Must enjoy working in a fast-paced, innovative environment. Must be flexible, proactive, efficient, and a team player.  This is a critical position which will require a self-starter with leadership, and interpersonal skills. Knowledgeable of ICH-GCP guidelines and major Health Authority regulations.
  • Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely
  • Ability to work independently and manage deadlines
  • Excellent interpersonal and communication skills (both written and oral) including ability to develop strong relationships with both internal and external customers in a matrix environment and to timely escalation conflicts for resolution.
  • Problem-solving, process improvement, analytical, and collaborative skills
  • Excellent oral, written, presentation and cooperation skills.
  • Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change
  • Experience with corrective/preventive actions and effectiveness checks

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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