Clinical Trial Start Up Associate/ Country Approval

vor 4 Wochen


Basel, Schweiz Thermo Fisher Scientific Vollzeit

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

At PPD, part of Thermo Fisher Scientific we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

We are looking for a Clinical Trial Start Up Associate/ Country Approval Associate to join our team in Switzerland. In this position you will be home-based and will be responsible for optimizing country strategies and ensure compliance with local requirements for the DACH region.

Key responsibilities:

- Manage clinical trial projects under guidance and lead local teams to achieve goals/milestones, work with international team to maintain timelines for start-up activities in alignment with global strategy
- Identify and escalate risks, develop proactive solutions to challenges
- Maintain trial status information in databases (filing, tracking of trial related documents)
- Gain and maintain knowledge of SOPs (standard operating procedures) and current regulatory regulations and guidelines in DACH region

To be considered for this exciting opportunity, you will have the following:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Fluency in German and French (either language at C2 level, and the other one C1 level), fluent English, Italian language is a plus
- Excellent time management, planning and prioritization skills
- Ability to work in a team environment or independently
- Proactive and self-reliance working behavior
- Outstanding negotiation and interpersonal skills
- Fast decision-making ability and result oriented approaches
- Strong attention to detail
- Creative, flexible, agile working attitude
- Ability to work well under pressure, managing multiple tasks and handle sensitive information with a high degree of confidentiality
- Good IT skills and ability to learn appropriate software

Our 4i Values:
Integrity - Innovation - Intensity - Involvement

LI-Remote #LI-BN1



  • Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting for a Clinical Trial Associate, on behalf of a mid-sized MedTech organisation based in Basel, Switzerland. This is a full-time, 12-month contract role with option to go permanent, offering hybrid / remote working. **Overview**: Our partner develop truly innovative drug-eluting devices for the treatment of complex cardiovascular...

  • Study Start-up Lead

    vor 4 Wochen


    Basel, Schweiz CK Group Vollzeit

    **Salary**:Up to CHF 69.70 per hour - **REF Number**:00056323 - **Consultant**:Jim Gleeson - **Contact**:01438 842973 - **Date Published**:21.11.2023 - **Sector**:Pharmaceutical - **Location**:Basel, Switzerland - **Discipline**:Clinical Operations CK Clinical are recruiting for a Study Start-Up Lead to join a global, blue chip pharmaceutical company, based...

  • Study Start-up Lead

    vor 4 Wochen


    Basel, Schweiz CK Group Vollzeit

    **Salary**:Up to CHF 69.70 per hour - **REF Number**:00056323 - **Consultant**:Jim Gleeson - **Contact**:01438 842973 - **Date Published**:21.11.2023 - **Sector**:Pharmaceutical - **Location**:Basel, Switzerland - **Discipline**:Clinical Operations CK Clinical are recruiting for a Study Start-Up Lead to join a global, blue chip pharmaceutical company, based...

  • Study Start Up Lead

    vor 2 Monaten


    Basel, Schweiz BeiGene Vollzeit

    General Description: - Drives, manages and leads all aspects of clinical study start up, from submission to site activation, Including Substantial amendment/modification activities on more than one study and/or multiple countries within the region. - Accountable for participating country SSU study deliverables and co-ordinates activities at local level,...


  • Basel, Basel-Stadt, Schweiz NES Global Deutschland GmbH NES Fircroft Vollzeit

    We have an exciting opportunity for a Clinical Trial Manager (M/F/d) in SwitzerlandTasks Collaborate with internal teams and External Service Providers for regulatory input in clinical trials and submission of CTAs to Health Authorities. Ensure timely preparation, submission, and maintenance of CTAs in compliance with regulatory requirements. Liaise with...


  • Basel, Schweiz IQVIA Vollzeit

    Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and...

  • Clinical Trial Manager

    vor 4 Wochen


    Basel, Schweiz IQVIA Vollzeit

    Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and...

  • Clinical Trial Manager

    vor 2 Monaten


    Basel, Schweiz NES Global Deutschland GmbH NES Fircroft Vollzeit

    We have an exciting opportunity for a Clinical Trial Manager (M/F/d) in Switzerland Tasks - Collaborate with internal teams and External Service Providers for regulatory input in clinical trials and submission of CTAs to Health Authorities. - Ensure timely preparation, submission, and maintenance of CTAs in compliance with regulatory requirements. - Liaise...

  • Study Start Up Lead

    vor 1 Woche


    Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    General Description: Drives, manages and leads all aspects of clinical study start up, from submission to site activation, Including Substantial amendment/modification activities on more than one study and/or multiple countries within the region. Accountable for participating country SSU study deliverables and coordinates activities at local level, ensuring...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **_T_**_he Life Science Career Network_** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a: **Drug Regulatory Affairs Clinical Trial Manager 100% - 5716 LBD** 10-month contract based in...


  • Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...


  • Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    General Description: Provides leadership to the European Study Start Up team, including defining and implementing strategy and key priorities to ensure fast study start up timelines Establishes and maintains effective communication and collaboration with functional area peers in Clinical Operations (e.g. Monitoring Excellence, Regional Study Management) and...

  • Study Start-up Lead

    vor 2 Monaten


    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The Position Clinical Trial Regulatory Lead The Pharma Development Regulatory (PDR) organization develops and maintains the licensees that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business to...


  • Basel, Schweiz Roche Vollzeit

    The Position Clinical Trial Regulatory Lead  The Pharma Development Regulatory (PDR) organization develops and maintains the licensees that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business...


  • Basel, Schweiz Manpower Vollzeit

    Mandated by one of our client companies, we are currently looking for an Associate Global Trial Director (AGTD). **General information** Workload: 90% - 100% Starting date**:ASAP,** as of June 1st Termination 31.12.2023 On-Site position Remote: to be discussed over interview - mandatory 3 days per week on site **Your mission** **Major...


  • Basel, Schweiz AL Solutions Vollzeit

    Clinical Research Scientist/Coordinator We are seeking an experienced Clinical Research Scientist/Coordinator to lead the global start-up of clinical trials from protocol finalization through site activation. Reporting to the Clinical Development Team, you will create and execute study start-up plans, manage country submission packages, and driving on-time...


  • Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Clinical Development Medical DirectorFor our client in Basel, we are looking for a medical doctor who will be the clinical leader of program level activities.(Duration: 12 months)Your responsibilities: Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable....


  • Basel, Schweiz Coopers Group AG Vollzeit

    Clinical Development Medical Director For our client in Basel, we are looking for a medical doctor who will be the clinical leader of program level activities. (Duration: 12 months) **Your responsibilities**: - Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program...


  • Basel, Schweiz BeiGene Vollzeit

    General Description: - Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget - Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned...