Clinical Trial Manager

Clinical Trial Manager

Seagen

Munich, Germany

Summary

The Clinical Trial Manager position has three primary responsibilities: Execution of clinical trial site monitoring functions of a clinical trial, management of staff (direct or indirect) within the Clinical Trial Management Team, and development of standards and practices within the clinical trial management group.

Principal Responsibilities

Responsibilities of a Clinical Trial Manager may include:

  • Acting as Protocol Lead on one or more clinical trials and serving as the main point of contact for clinical site management and clinical trial site monitoring functions;
  • Participating as a member on assigned cross functional study team;
  • Assisting with the design and review of clinical trial protocols, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups. Participating in the Clinical Protocol Committee as appropriate;
  • Creating and maintaining clinical trial start-up documents such as the Clinical Monitoring Plan Developing or providing clinical operations/clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate;
  • Leading identification, evaluation and selection of clinical trial investigators/sites;
  • Managing clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc.) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals;
  • Providing support to Field Clinical Research Associates (CRAs) and assisting in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. Conducting monitoring visits including pre study, initiation, interim monitoring and close visits as needed;
  • Coordinating and managing vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO);
  • Being the primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work;
  • Overseeing research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed;
  • Facilitating information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate;
  • Ensuring completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies;
  • Assisting in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as regulatory authority inspections;
  • Leading functional teams within the Clinical Trial Management department.

Management responsibilities of a Clinical Trial Manager include:

  • Working with department directors to set goals for the Clinical Trial Management Team;
  • Problem-solving clinical team personnel issues;
  • Managing internal (dotted line or functional) and Field CRAs, and other external clinical trial service vendors as necessary. Providing timely feedback to assigned staff on personal and project-specific performance, and providing guidance on performance improvements as necessary;
  • Performing performance evaluations and providing assigned staff with constructive feedback to enhance performance. Serving as mentor to help assigned staff develop their career paths;
  • Ensuring staff training is adequate and documentation of training is up to date.

Infrastructure development and maintenance responsibilities of a Clinical Trial Manager may include:

  • Assuming responsibility for development and maintenance of department SOPs or processes;
  • Becoming a subject matter expert for complex processes within the clinical trial management team;
  • Ensuring assigned team (dotted ine or functional) adheres to clinical operations or project-specific quality documents (e.g., SOPs, work practices, training guides);
  • Participating in maintenance and updating of job descriptions;
  • Participating in the screening, evaluation and hiring process for assigned open Clinical Development Operations positions;
  • Leading department initiatives that drive process improvement.

Qualifications

  • 5-8 years of relevant Pharmaceutical/Biotech/CRO Industry experience preferred;
  • Experience in Phase I-III trials and CRO management is preferred;
  • Experience managing large teams (direct or dotted line reporting) is preferred;
  • Oncology clinical research experience preferred;
  • Ability and willingness to travel (domestic and internationally);
  • Thorough knowledge of CFR and GCP/ICH requirements. Knowledge of European Clinical Trial Directive is preferred;
  • Excellent communication and organization skills;
  • Exceptional ability to plan, organize and manage clinical trials;
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).

Education:

  • BA/BS or equivalent or any relevant and qualifying training;
  • An advanced degree is preferred.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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