Clinical Trial Submission Manager

Werkgever CheckMark Labrecruitment
Plaats Regio Leiden
Provincie Zuid-Holland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum woensdag 25 april 2018
Sluitingsdatum woensdag 23 mei 2018

Direct solliciteren

Functieomschrijving

You use your knowledge to carefully guide the start-up and submission of clinical trials. You manage regulatory aspects of clinical trials, contact health authorities and help to ensure quality and completeness throughout the lifecycle of the trial

As Clinical Trial Submission Manager you have a senior role in the clinical department. You apply your knowledge, network and (trial)management skills to make sure that regulatory clinical trial submissions are efficient, compliant and well-managed. 

- Following the global submission strategy, you ensure the quality and completeness of the Clinical Trial Application (CTA) regulatory submissions for products in several disease areas. you do so throughout the lifecycle of the trial
- This way, you monitor that the required regulatory intelligence is in place to comply with country-specific requirements
- For this purpose you will lead a cross-functional team that will compile, publish and produce Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
- Moreover, you interact with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
- Lastly, you ensure that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system
- This position is mainly based in the office and thus preferably an on-site (and not a home-based) role

Profiel

Opleiding WO
Ervaring Ervaren (3 - 8 jaar)
As a Clinical Trial Submission Managerr you meet the following requirements

- Bachelor's(BSC), Master (MSc) of PhD degree in pharmaceutical or health sciences, which makes you knowledgeable with scientific terminology
- You have at least 4 years of work experience in the phramaceutical industry in regulatory affairs, as clinical trial manager, clinical research associate and/or start-up manager of clinical studies 
- This gives you a sound understanding of drug development, clinical trial authorization applications, Knowledge of associated regulatory affairs, and legal requirements is also required
- Moreover, you should have strong communication skills (written and verbal), as frequent interactions with stakeholders (e.g. Health Authorities, Local Operating Companies, Clinical Teams etc) occur
- You have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency) and are able to lead complex projects.
- You can work well independently, can build strong and productive relationships, have excellent problem solving capabilities and influencing skills
- You are fluent in English

Aanvullende informatie

- Secondment contract via Checkmark untill he end of this year
- Good perspectives to stay at the company therafter
- Fulltime availability is preferred, though 4 days (32 hours) is possible as well
- This is an office-based position

Contact

Neem voor meer informatie contact op met  Coen Smiers: 0182 590 218 // 06 218 999 66
Vacaturenummer: 5800

Bedrijfsprofiel

A large pharamceutical company

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