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Global Trial Manager

  Actelion is a biopharmaceutical company founded in 1997, headquartered in Allschwil/Basel, Switzerland.
Today with about 2'000 people in 28 countries we focus on discovery, development and marketing of original, innovative drugs for highly unmet medical needs. Actelion combines the innovation, entrepreneurial spirit and flexibility of biotech with the financial, risk management, regulatory and commercial discipline of a large pharmaceutical company. We have ambitious plans to keep improving and growing - and are looking for people as inovative as ourselves.
 
     
  Global Trial Manager  
 
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a Global Trial Manager in Cherry Hill, New Jersey.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

REQUIRED QUALIFICATIONS AND EXPERIENCE
  • Bachelor of Science degree or equivalent University education/degree in life sciences or healthcare
  • Minimum of 7 years' clinical trial experience with a minimum of 5 years' experience in managing Phase II and III clinical trials
  • Experience in executing a wide range of clinical trial activities from study start up to clinical study report
  • Experience in managing complex trials, e.g., Phase III trials, difficult patient populations, managing outsourced trials
  • Experience in managing External Service Providers (ESPs) including performance assessments and finance management (invoice review, change order management, budget reforecasting, etc.)
  • Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
  • Experience in managing global teams in a virtual environment
  • Proven track record for delivering clinical trials within time, budget, and quality expectations
  • Strong project management expertise
  • Strong interpersonal, communication (written and verbal) and organizational skill
  • Self-motivated and able to work effectively in a matrix/team environment
  • Excellent knowledge of International Council for Harmonization/Good Clinical Practice (ICH-GCP) including international regulatory requirements for the conduct of clinical development programs in key regions (Americas, Europe, Asia Pacific, and Australia)
  • Fluent in English; fluency in other languages preferred
  • Advanced computer skills (e.g., Microsoft Office, Word, Excel, PowerPoint)
  • Available to travel domestically and internationally
  • Strong leadership skills
  • Able to demonstrate ownership and initiative
  • Demonstrated decision-making and problem-solving skills

RESPONSIBILITIES AND TASKS
  • Work closely with Clinical Development Operations (CDO) group members, e.g., Global Trial Leader, Country Clinical Monitoring Manager, Clinical Research Associates, etc., for trial-related activities at a country/site level (e.g., site initiations, site closures, import/export licenses, TMF, contracts, invoices, ESPs, submission to Health Authorities, ECs/IRBs
  • Assist and provide input into the Clinical Trial Plan (CTP)
  • Manage trial activities and ensure delivery of global operational output in accordance with the CTP, timelines, and budget
  • Ad hoc CDO member at Clinical Trial Team (CTT) meetings
  • Work closely with cross-functional group (e.g., CTT members, Technical Operations, Clinical Trial Supplies members
  • Chair Project Management Team (PMT) meetings, ensure a two-way flow of information is maintained between the PMT and CTT, and ensure timely follow-up on agreed upon actions
  • Ensure adequate trial-specific training of assigned CDO team
  • Participate in the selection, training, and management of ESPs
  • Oversee performance of ESPs to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to GTL
  • Perform review of ESP invoices to ensure that work is performed in accordance with scope of work
  • Create the global investigator budget and payment schedules as appropriate
  • Contribute to preparation and/or review of all trial-related documents, (e.g., protocol, monitoring guidelines) in collaboration with other team members
  • Forecast global supply needs, order supplies, and ensure timely distribution globally (IMP and other materials). Ensure close interactions with Technical Operations-Clinical Trial Supply (TOP CTS) throughout the trial
  • Organize and supervise preparatory activities for the Investigator meetings, as well as participate and present at the meetings
  • Contribute to CRA trainings
  • Perform ongoing quality checks/review of the Study Master File (StMF) and ensure completeness and audit-readiness of the CDO section of the TMF
  • Ensure trial information is kept up-to-date in Actelion's clinical trial management and documentation
  • Assume responsibility for other project or trial-related duties as assigned

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.
 
     
  Please apply electronically through our website:

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