Senior Clinical Project Manager- Oncology

Location
Cambridge, MA, United States
Posted
Oct 17, 2020
Ref
R-06290
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Title:
Senior Clinical Project Manager- Oncology

Company:
Ipsen Bioscience, Inc.

Job Description:
As Sr. Clinical Project Manager, you will be accountable for the clinical trial execution and management of all aspects of the assigned global international oncology clinical study(ies) outsourced to a CRO with respect to planning, managing timelines, quality, budget and defined goals. You will drive execution and report study activities in conjunction with Clinical Development Program Directors, Medical Development Directors (MDDs), and other Ipsen team members. Your role will involve: Ensure study team management and communication
  • Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget for one study or more within a clinical program
  • As directed by Line manager, manage, coach and develop some Clinical Operation team members assigned to the study or program
Lead clinical project execution
  • Support the CDPD and collaborate closely to define study or program strategic direction and might represent the CDPD to project or asset team meetings, as needed
  • Lead cross-functional clinical study teams focused on conduct of assigned projects
  • Review and analyze status reports provided by Service Provider/CRO and highlight issues to facilitate decision making and escalate as required
  • Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study feasibility to CSR, in respect of GCPs, Regulatory requirements and relevant SOPs
Key accountabilities and activities
  • Set-up study team before Services Provider / CRO are on board and lead and manage regular internal Study Team meetings during the course of the study.
  • Develop and control planning and study timelines in collaboration with all other Ipsen supportive functions/CRO
  • Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO
  • Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports
  • Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document
  • Review final draft and approve major study documents as described in the Services Providers /CROs Technical Specification documents (e.g. oversight manual, communication plan, project plan, instruction manuals….)
  • Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites
  • Provide support and oversee the activities of the Clinical Trial Assistant (CTA) assigned to the study for: insurance certificate, contracts signature process, set-up and management of the Trial Master File (eTMF), transparency and local reporting as per legal and Ipsen requirements, update of reporting tools (study trackers, Hermes,…) and alert if required; drive billing and forecast
  • As applicable, provide support and oversee the activities of the Clinical Monitoring Lead (CL) to ensure the coordination of the clinical, monitoring and site management activities are in accordance with study objectives and quality standards.
Travel RequirementsThe position will be predominantly office based though travel will be a necessary pre-requisite in order to effectively support the Group and the projects In return, you will bring: Relevant experience of pharmaceutical drug development:
  • Minimum of 10 years working in clinical research with management of clinical development studies for at least 8 years
  • Experience in managing and developing relationships with Contract Research Organizations (CROs)
  • Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.
  • Oncology experience preferred
Qualifications:
  • Life science or medical graduate or other relevant qualifications
  • Intimate knowledge of regulatory requirement (ICH E6, GCP, EU Directive)
  • Languages: English language knowledge (oral and written)
  • Excellent leadership skills and capability to work within a team as leader and team player,
  • Excellent organizational and management skills with ability to delegate and set priorities
  • Strong verbal and written communication skills (English) with the ability to communicate effectively at different levels of the organization
If this sounds like an exciting opportunity to apply your clinical project management skills on our Clinical Operations team, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.","datePosted":"2020-10-16T00:00:00.000Z