Germany Job Openings
ICON
CTA submission manager
FULL TIME
October 11, 2024
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
The CTA Submission Manager is accountable for submissions execution for designated CTAs.
ROLE RESPONSIBILITIES:
- Drives global submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes
- Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
- CTA Manager may act as local country liaison when required
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
Qualifications -
- S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of CTA and Central Ethics processes globally
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
#LI-PH1
New Job Alerts
Pwc Germany
Rechtsreferendar Legal (w/m/d)
Frankfurt am Main
FULL TIME & PART TIME
November 19, 2024
View Job Description
Pwc Germany
Praktikum / Werkstudent Legal (w/m/d)
Berlin
FULL TIME & PART TIME
November 19, 2024
View Job Description
implantcast
Ingenieur:in / Meister:in / Techniker:in als Teamleiter:in Finish Medizintechnik
Buxtehude
November 19, 2024
View Job Description
Pava Partners Germany AG
Vice President/Director M&A (m/w/d)
Leipzig
FULL TIME
November 19, 2024
View Job Description
Löwenstein Medical SE & Co. KG
Leiter entwicklungsbegleitendes Qualitätsmanagement für Medizinprodukte (m/w/d)
Hamburg
November 19, 2024
View Job Description
Havas Group
Werkstudent/in im Bereich Online/ Digital Marketing (all gender)
Frankfurt am Main
PART TIME
November 19, 2024
View Job Description
Schenk Tanktransport
Tankwagenfahrer (m/w/d) für die Ausfuhr technischer Gase
Leuna
FULL TIME
November 19, 2024
View Job DescriptionLooking for similar job?
Rosewood Hotel Group
Food & Beverage Operations Manager
Munich
FULL TIME
October 7, 2024
View Job Description
osapiens Services GmbH
Senior People Operations Manager
Mannheim
FULL TIME
October 7, 2024
View Job Description
Otter Products, LLC
Junior Key Account Manager
Munich
FULL TIME
October 7, 2024
View Job Description
Life Science Nord Management GmbH
Project Manager (m/w/d) Medical Devices
Hamburg
FULL TIME
October 7, 2024
View Job DescriptionLife Science Nord Management GmbH
Risk & Regulatory Affairs Manager (m/w/d) Medical Devices
Hamburg
FULL TIME
October 7, 2024
View Job DescriptionSee What’s New: ICON Job Opportunities
ICON
Contracts Associate / Home Based / Sponsor Dedicated
FULL TIME
October 17, 2024
View Job Description
ICON
Jr. Clinical Research Associate / Home Based / Sponsor Dedicated
FULL TIME
October 15, 2024
View Job Description
ICON
Sr. Clinical Research Associate / Home Based / Sponsor Dedicated
FULL TIME
October 15, 2024
View Job DescriptionNew Job Alerts
Pwc Germany
Rechtsreferendar Legal (w/m/d)
Frankfurt am Main
FULL TIME & PART TIME
November 19, 2024
View Job Description
Pwc Germany
Praktikum / Werkstudent Legal (w/m/d)
Berlin
FULL TIME & PART TIME
November 19, 2024
View Job Description
implantcast
Ingenieur:in / Meister:in / Techniker:in als Teamleiter:in Finish Medizintechnik
Buxtehude
November 19, 2024
View Job Description
Pava Partners Germany AG
Vice President/Director M&A (m/w/d)
Leipzig
FULL TIME
November 19, 2024
View Job Description
Löwenstein Medical SE & Co. KG
Leiter entwicklungsbegleitendes Qualitätsmanagement für Medizinprodukte (m/w/d)
Hamburg
November 19, 2024
View Job Description
Havas Group
Werkstudent/in im Bereich Online/ Digital Marketing (all gender)
Frankfurt am Main
PART TIME
November 19, 2024
View Job Description
Schenk Tanktransport
Tankwagenfahrer (m/w/d) für die Ausfuhr technischer Gase
Leuna
FULL TIME
November 19, 2024
View Job Description