Global Senior Clinical Trial Manager
|Global Senior Clinical Trial Manager
|about 2 years ago
Our client, a Biopharma company with strong development pipeline and multiple blockbuster products, now seeks a Senior Clinical Trial Manager who will lead global clinical study and cross-functional study team. This hire will be the primary point of contact of leadership and oversight for the assigned study, with responsibility for clinical study delivery.
The successful candidate is accountable for the global execution of assigned large and/or complex Phase II and III clinical trials from study design, through execution, to study close out. This includes oversight of large global vendors managing their delivery to: study timelines, study budget, and ensuring study conduct is in accordance with SOPs and ICH/GCP.
This hire will oversee set-up and maintenance of study systems including CTMS, TMF, etc. Also this hire will identify outsourcing needs of the study and lead / oversee engagement, contracting and management of required vendors.
The ideal candidate will be an experienced CTM with have proven ability to understand and implement the strategic direction for respective clinical studies, with the ability to work effectively in a dynamic environment.
Responsibilities of Global Senior Clinical Trial Manager:
Oversees and provides input to the development of study specific documentation including: CRF, data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
Responsible for direct supervision of CTM staff and line management responsibilities.
Ensures compliance with the clinical trial registry requirements.
Provides input into baseline budget & timeline development and management.
Leads risk assessment and identifies risk mitigation strategies at the study level.
Leads the feasibility assessment to select relevant regions and countries for the study.
Oversees/conducts site evaluation and selection.
Leads investigator meeting preparation and execution.
Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan.
Ensures accurate budget management and scope changes for internal and external studies.
Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation.
Communicates study conduct, quality, timelines or budget to Program Director and other stakeholders, and develops and implements appropriate actions to address issues.
Oversees the execution of the clinical study against planned timelines, deliverables and budget.
Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites.
Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work.
Ensure clinical project audit and inspection readiness through the study lifecycle.
Manages and oversees study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs.
Requirements for Global Senior Clinical Trial Manager:
Bachelor’s degree and minimum of 8+ years relevant Clinical Operations experience, some of which as Clinical Trial Manager. Ideally some experience within Pharma, Biopharma or Sponsor company.
Experience of managing vendors (e.g. CROs, etc) including clinical trial progress and delivery.
Experience in global clinical trial operations management, including experience: developing protocols and key study documents in line with knowledge of ICH/GCP and regulatory guidelines/directives.
Effective project management skills, cross-functional team leadership and organizational skills.
Line management experience and ability to build productive teams and collaborations
Demonstrated vendor management experience and budget management experience.
Technical proficiency in trial management systems and MS applications including; Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
Effective communication skills via verbal, written and presentation abilities
Ability to influence and negotiate.
For further details please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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