Clinical Trials Group Manager
Clinical Trials Group Manager - (1800000P) Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson &
Johnson, is recruiting for Clinical Trials Group Manager.
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.
Tasks related to Clinical Trial Applications (CTAs):
- Interact with internal departments or teams, affiliates and third parties as required to give regulatory input and
guidance for clinical trials and their submission to European and international Health Authorities (HAs).
- Prepare, submit and maintain CTAs to European and international HAs in accordance with the applicable regulatory
- Liaise with Actelion internal, regional, affiliate and/or CRO personnel to request and collect appropriate documents
and, where applicable, to arrange submission.
- Interact with HAs and/or other parties regarding CTAs.
- Ensure proper running of the trial during its life cycle from a regulatory perspective.
- Ensure that timelines are met for submissions such as End of Trial notifications, Clinical Study Report synopsis,
answers to HA questions, etc.
- Maintain tracking sheets listing submission and approval dates per country for initial CTA, amendments, End of Trial
Notifications and submission of Clinical Study Report synopsis.
- Maintain the relevant sections of the Trial Master File for the duration of the clinical trial and prepare and QC
the documentation before arranging final transfer.
Tasks related to the Clinical Trial Team (CTT):
- Attend and contribute to CTT meetings, providing regulatory updates and information as required.
- Discuss country timelines and prioritize submissions in conjunction with relevant CTT members.
- Provide advice to CTT members on HA CTA submission processes and other related submissions, such as amendments, End
of Trial notifications, etc.
- Keep the relevant CTT members informed of the status of HA-related matters, including forwarding copies relevant
documentation in a timely manner.
- Line management (including mentoring) of members of the DRA Clinical Trials Group.
- Train and support new and existing DRA Clinical Trial Managers with their daily tasks.
- For applicable countries, liaise with Actelion internal, regional, affiliate and/or CRO personnel to manage
submissions related to import/export licenses, including following-up on status of submission and providing input to
- Contribute to update of existing and creation of new internal SOPs and processes.
- Final sign-off of IMP Shipment Approval requests for relevant departments.
- Keep country-specific information updated and inform other members of the CTA group accordingly.
- Appropriate experience in the field of Clinical Trial Applications (CTAs), gained either as a DRA Clinical Trial
- Manager within Actelion, or externally
- Good organizational and communication skills
- Committed attention to detail combined with the ability to maintain an overview of ongoing projects
- Team spirit and team leadership skills
- The ability to prioritize tasks and work to deadlines
- Initiative and flexibility
- Customer oriented
- Excellent MS Office skills
- Excellent spoken and written English
- Knowledge of any other European language would be an advantage
: Regulatory Affairs
: Jan 18, 2018