Senior Clinical Research Associate - FSP (Level II)

Thermo Fisher Scientific
Switzerland
Télétravail
Cette offre d'emploi n'est pas disponible dans votre pays.

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Essential functions :

Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective / preventive actions to bring the site into compliance and decrease risks.

Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.

Documents observations in reports and letters in a timely manner using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.

May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.

Conducts monitoring tasks in accordance with the approved monitoring plan.

Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues / findings resolution.

Investigates and follows-up on findings as applicable.

  • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client to ensure the acceptability
  • of qualified investigative sites. Initiates clinical trial sites according to the elevant procedures to ensure compliance with the protocol and regulatory and
  • ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according
  • to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
  • Provides trial status tracking and progress update reports to the Clinical Team
  • Manager (CTM) as required. Ensures study systems are updated per agreed study conventions ( Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and / or electronic contacts.
  • Responds to company, client and applicable regulatory requirements / audits / inspections.
  • Maintains & completes administrative tasks such as expense reports and timesheets on time.
  • Contributes to the project team by assisting in preparation of project publications / tools and sharing ideas / suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required

Education and Experience :

  • Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years as a clinical research monitor).
  • Valid driver's license where applicable.

Knowledge, Skills and Abilities :

  • Proven clinical monitoring skills
  • Demonstrated understanding of medical / therapeutic area knowledge and medical terminology
  • Proven ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents
  • Well-developed critical thinking skills, including but not limited to : critical mindset, in-depth investigation and appropriate problem solving
  • Ability to manage Risk Based Monitoring concepts and processes
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
  • Good organizational and time management skills
  • Effective interpersonal skills
  • Attention to detail
  • Ability to remain flexible and adaptable in a wide range of scenarios
  • Ability to work in a team or independently as required
  • Ability to travel 4-6 times per month
  • Good computer skills : solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English and German language skills. In addition, French and Italian will be a plus

What We Offer :

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team.

We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

We have a , where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Il y a plus de 30 jours
Emplois reliés
Thermo Fisher Scientific
Switzerland
Télétravail

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Previous experience that provides the knowledge, skills, and a...

TFS HealthScience
Winterthour, Zurich

As a Senior Clinical Research Associate with TFS HealthScience, you will be a vital part of our SRS/FSP team, working exclusively with a world-renowned global pharmaceutical/biotech sponsor. With expertise in full-service capabilities, resourcing, and Functional Service (FSP) solutions, we’re lookin...

Thermo Fisher Scientific
Switzerland
Télétravail

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Our clinical department defines, develops and delivers clinica...

Envista
Kloten, Zurich
Télétravail

We are looking for a highly motivated team member to join our Clinical Operations team in Zurich as a Clinical Research Associate. Support timely delivery of clinical investigation in collaboration with study-assigned Clinical Research Manager (CRM). Support statistical evaluation of study results w...

Pharmiweb
Lausanne, Vaud

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidel...

CK Group
Switzerland

Minimum 1-2 years clinical research experience in a Contract Research Organization (CRO) or Pharmaceutical Company with experience in monitoring on-site clinical trial. CK QLS are recruiting for a Clinical Research Associate to join our client based in Basel, on a 12 month contract. Informed Consent...

PSI
Zug Ville, Zoug
Télétravail

Performs clinical supplies management with vendors on a country and regional level. Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. Ensures proper handling, use, accountability, reconciliation, a...

Cytel
Switzerland

As a Senior Biostatistician you will support Cytel and a client of our Functional Service Provider (FSP) division's Pre-Clinical Development activities. Cytel's Functional Service Provider (FSP) department offers statistical programmers, biostatisticians and clinical data specialists amazing opportu...

Offre sponsorisée
CTC Resourcing Solutions AG
Bâle, Basel-City

Das Life Science Karriere Netzwerk.CTC vereint Experten aus den Bereichen Life Sciences und Personalwesen.Wir helfen Unternehmen die besten Talente zu finden und zu binden; mit unseren Projekten unterstützen wir sie innovative Behandlungsmethoden für Patienten zu entwickeln und umzusetzen.Unsere Kan...

Offre sponsorisée
Hans Leutenegger AG - Bern
Berne Ville, Berne

Ausführen diverser Malerarbeiten im Innen- und Aussenbereich.Fassaden, Fenster, Metall, Holz, Türen und Kunststoff streichen.Spannende Einsätze auf vielfältigen Baustellen .Selbständiges Arbeiten in einem dynamischen Team .Faire Bezahlung und gute Arbeitsbedingungen.Möglichkeiten zur Weiterbildung ....