Website PharmiWebJobs Global Life Science Jobs
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Are you looking for a new challenge?
Are you an SSU Specialist craving career progression?
Do you want to work for a company that values culture?
Yes? Then this is the role for you!
Study Start-Up & Regulatory Specialist LEAD ROLE – Permanent – NL ONLY
i-Pharm Consulting are partnering with a fully integrated biopharmaceutical solutions organization, which is purpose-built to accelerate customer success. You will be able to collaborate with a range of passionate problem solvers, innovators and a general team who are focussed on helping customers achieve their goals.
We are calling on a Study Start-Up Specialist Lead to join their SSU team in the Netherlands. This is an awesome opportunity to secure some excellent experience under your belt. This model has excellent attrition and recent growth within the team ensuring guaranteed development opportunities and a happy and stable working environment.
Why this CRO?
- This CRO are passionate about developing people either through career development and progression, whilst ensuring supportive and engaged line management along with appropriate therapeutic area training, peer recognition and a total rewards program.
- They have a commitment to a ‘Total Self culture’ whereby you can be the most authentic version of yourself. They have a huge dedication to taking care of their employees in every way possible.
- It does not matter where you come from, what your background or culture is – they want to ensure that they create a place where everyone can feel like they belong.
What can you expect from the role?
- Responsible for the quality deliverables at the country level which includes following project requirements in line with country rules and liaising with the SSU Country Manager.
- Work within the forecasted submission/approval timelines.
- Provide support on contingency plans to mitigate impact and escalate any issues as soon as they are identified.
- Support continuous improvement of quality in all Site Start-Up (SSU) components at a country level where assigned.
- Local Submissions Specialist must follow the project direction provided by the designated country start-up advisor (CSA) and SSUL.
- (At lead level) Serve as a point of contact for the PM/SSUL during start-up on allocated projects.
- Review essential document packages for site activation and possibly be involved in essential document collection from site.
- Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Prepare ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory committees as needed within the country, including safety notifications.
- Provide support with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Ability to negotiate contract and budgets and provide support to SSUL to agree on country template contract and budget.
- Produces site-specific contracts from country template.
- Provide support in submissions for proposed contract and budget for site.
- Perform quality control and arrange execution of CTAs as well as archival of documents into repositories.
- Netherlands based only
- Potential travel of up to 30%
- Up to €75k + benefits.
What will be required of you?:
- Excellent understanding of current GCP/ICH compliance as well as law and guidelines.
- Detailed understanding of clinical trial start-up processes.
- Understanding of clinical trials methodology and terminology.
- Good time management, organisational as well as interpersonal and problem-solving skills.
- Ability to manage external vendors to contract effectively.
- Ability to manage multiple project budgets with increased complexity and value.
- Good negotiating skills.
- Demonstrated ability to work as an independent operator as well as part of a team.
- Fluent in Dutch and English
ABOUT I-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
If you would like to discuss this vacancy further, please call Almeera Sheikh on +31 (0)202 410 152, or email [email protected] If this role is not suitable, Almeera is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
SSU/ SSU Lead/ Study Start-up /Start-Up / CRO / Contract Research Organisation / Pharma/ Biotech/ Medical Devices/ Drug Trials/ Respiratory/ Malignant Pain/ Phase II / Phase III/Site Contract Specialists/ Home Based /Benelux /Nederland/ Netherlands
Company: PharmiWebJobs Global Life Science Jobs
Vacancy Type: Full Time
Job Location: Teruel
Application Deadline: N/A