Post-Trial Access Coordinator (m/f)

REFERENCE NUMBER:

383215/11

MY DUTIES:

-Establishes, maintains and fosters strong relationships with key stakeholders and ensures

an efficient, effective and compliant PTA management -Develops and maintains effective working relationships with (G)IMDs, PTA team members,
Affiliate teams and vendors -Ensures receipt, filing and tracking of PTA records (SDEAs, Physician’s Agreements,
Regulatory Forms, other country specific documents) in the required quality -Manages timely interaction between relative CLinOps colleagues in PDMA (ICTMs/ICPL) or
PDG (GSLs/OPLs) and the Clinical Drug Supply Leads in Pharma Technical in order to ensure proper preparation and delivery of the PTAP drug supply -Manages Touchpoint (filing area, affiliate area) and RecPoint (records) program area according to global standards, including set up, access rights and maintenance of program
Related documents; -Responsible for project management, tracking of milestones and timelines, and timely data
Entry in MDMS/CTMS

MY QUALIFICATIONS:

-Life sciences degree or nursing degree or post graduate degree in life sciences, medical or equivalent area
-Professional experience in the pharmaceutical /clinical research industry
-Preferably in clinical development
-Broad understanding of global expectations of Health Authorities
-International clinical trial management experience
-Proven track record of working cross-functionally and in global matrix teams with
-Considerable organizational awareness (e.g. inter-relationship of departments, business processes)
-Strong Project/program management experience
-Excellent Knowledge of ICH/ GCP
-Knowledge of drug development and regulatory requirements for the conduct of clinical

trials -Familiarity with clinical operations practices
-Fluency in written and spoken English

MY BENEFITS:

-You will work in an international environment
-Option to be extended

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.