Aktuelle Jobs im Zusammenhang mit Clinical Research Specialist - Munich, Bayern - Thermo Fisher Scientific
-
Munich, Bayern, Deutschland Innovaderm Research VollzeitClinical Research Associate II or Clinical Research AssociateThis role involves monitoring the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory...
-
Clinical Research Associate
vor 4 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical...
-
Clinical Research Associate
vor 4 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical...
-
Clinical Research Associate
vor 3 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical...
-
Clinical Research Associate
vor 3 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical...
-
Clinical Research Associate
vor 1 Monat
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking an experienced Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical studies.Key...
-
Clinical Research Associate
vor 1 Monat
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking an experienced Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical studies.Key...
-
Clinical Research Associate
vor 4 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking an experienced Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical studies.Key...
-
Clinical Research Associate
vor 4 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAbout the RoleWe are seeking an experienced Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our global Clinical Operations colleagues to ensure the delivery of high-quality, cost-efficient clinical studies.Key...
-
Clinical Services Engagement Associate, Germany
vor 2 Wochen
Munich, Bayern, Deutschland WCG Clinical VollzeitJob Summary:Clinical Services Engagement Associate works in a pivotal role of managing communication and activities among clinical research sites, and internal stakeholders to prepare for and complete clinical assessments in accordance to the project specific scope of work.Key Responsibilities:Partner with external customers such as clinical research sites,...
-
Clinical Research Associate
vor 2 Wochen
Munich, Bayern, Deutschland Thermo Fisher Scientific VollzeitAt Thermo Fisher Scientific, we are seeking a skilled Clinical Research Associate to join our global clinical operations team. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials by ensuring compliance with regulatory requirements and ICH-GCP guidelines.Key Responsibilities:Perform and coordinate all aspects...
-
Senior Clinical Project Manager
vor 2 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob SummaryWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a key member of our clinical operations team, you will be responsible for managing clinical trials from start to finish, ensuring timely and within-budget delivery of high-quality results.Key ResponsibilitiesManage clinical trials from...
-
Clinical Services Engagement Associate
vor 3 Wochen
Munich, Bayern, Deutschland WCG Clinical VollzeitJob SummaryClinician Services Engagement Associate plays a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with project-specific scope of work.Key ResponsibilitiesPartner with external customers, such as clinical research sites, and...
-
Clinical Services Engagement Associate
vor 3 Wochen
Munich, Bayern, Deutschland WCG Clinical VollzeitJob SummaryClinician Services Engagement Associate plays a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with project-specific scope of work.Key ResponsibilitiesPartner with external customers, such as clinical research sites, and...
-
Senior Clinical Project Manager
vor 4 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob Title: Senior Clinical Project ManagerWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key Responsibilities:Lead clinical trials...
-
Senior Clinical Project Manager
vor 4 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob Title: Senior Clinical Project ManagerWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key Responsibilities:Lead clinical trials...
-
Senior Clinical Project Manager
vor 4 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob Title: Senior Clinical Project ManagerWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key Responsibilities:Lead clinical trials...
-
Senior Clinical Project Manager
vor 4 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob Title: Senior Clinical Project ManagerWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key Responsibilities:Lead clinical trials...
-
Senior Clinical Project Manager
vor 4 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob Title: Senior Clinical Project ManagerWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key Responsibilities:Lead clinical trials...
-
Senior Clinical Project Manager
vor 4 Wochen
Munich, Bayern, Deutschland Innovaderm Research VollzeitJob Title: Senior Clinical Project ManagerWe are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key Responsibilities:Lead clinical trials...
Clinical Research Specialist
vor 3 Monaten
At Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Our mission is to empower our clients to enhance health, safety, and environmental quality. We equip our teams with the necessary resources to achieve personal career aspirations while advancing scientific research through the development and delivery of transformative therapies. With clinical trials executed in over 100 countries and continuous innovation in clinical research frameworks through our PPD clinical research portfolio, our efforts encompass laboratory, digital, and decentralized clinical trial services. Your commitment to delivering quality and precision will enhance health outcomes that communities rely on now and in the future.
Our clinical division is responsible for defining, developing, and executing clinical programs. Our global Clinical Operations team within our PPD clinical research services offers comprehensive support for clinical trials from initiation to monitoring and finalization, covering both commercial and governmental contracts. Together, we assist clients in outlining and developing clinical programs, reducing delays, and conducting high-quality, cost-effective clinical studies.
We are currently seeking experienced Clinical Research Associates at all levels. Positions are available in various locations throughout Germany, with options for fully remote, fully office-based roles in our Munich or Karlsruhe offices, or a hybrid model. We are open to full-time or 80% FTE arrangements. All positions are permanent.
Responsibilities of the Clinical Research Associate:
- Oversee and coordinate all facets of clinical monitoring and site management processes.
- Conduct remote or on-site evaluations to ensure adherence to protocols and regulatory standards while managing necessary documentation.
- Serve as a specialist in site processes, ensuring trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to safeguard subject rights, well-being, and data integrity.
- Maintain audit readiness.
- Foster collaborative relationships with investigational sites.
- Specific tasks and responsibilities are detailed in the task matrix.
A Day in the Life:
- Monitor investigator sites using a risk-based approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify failures in site processes and implement corrective/preventive actions to ensure compliance and mitigate risks.
- Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) assessments during on-site and remote monitoring activities.
- Evaluate investigational products through physical inventory checks and records review.
- Document findings in reports and correspondence promptly, adhering to approved business writing standards.
- Promptly communicate observed deficiencies and issues to clinical management and ensure follow-up until resolution.
- Maintain regular communication with investigative sites between monitoring visits to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
- Conduct monitoring tasks in line with the approved monitoring plan.
- Participate in the investigator payment process.
- Share responsibility with other project team members for issue and finding resolution.
- Investigate and follow up on findings as necessary.
- Provide trial status tracking and progress reports to the Clinical Team Manager (CTM) as required.
- Ensure study systems are updated according to agreed study conventions (Clinical Trial Management System, CTMS).
- Perform quality control checks on reports generated from the CTMS system as needed.
- Participate in investigator meetings as required.
- Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory obligations, making recommendations as warranted. Ensure trial closeout and retrieval of trial materials.
- Ensure that essential documents are complete and compliant with ICH-GCP and applicable regulations. Conduct on-site file reviews as per project specifications.
- Contribute to project teams by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members. Perform additional study tasks as assigned by the CTM (e.g., trip report review, newsletter creation, leading CRA team calls).
- Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral, and electronic means.
- Respond to company, client, and applicable regulatory requirements/audits/inspections.
- Complete administrative tasks such as expense reports and timesheets in a timely manner.
- Contribute to other project work and initiatives aimed at process improvement as required.
Education and Experience:
- Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
- Prior experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
- Valid driver's license.
- Full right to work in Germany.
- Fluency in English and German at a minimum C1 level (note that the interview will be conducted in German).
Knowledge, Skills, and Abilities:
- Effective clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.
- Well-developed critical thinking skills, including but not limited to: critical attitude, in-depth investigation for appropriate root cause analysis, and decision-making.
- Ability to handle Risk-Based Monitoring concepts and processes.
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
- Ability to maintain customer focus through good listening skills, attention to detail, and the ability to perceive underlying issues.
- Strong social skills.
- Strong attention to detail.
- Effective organizational and time management skills.
- Ability to remain flexible and adaptable in various scenarios.
- Ability to work independently or as part of a team as required.
- Proficient computer skills: strong knowledge of Microsoft Office and the ability to learn relevant software.
- Good presentation skills.
