About this role
TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.
As part of our SRS/FSP team, you will be dedicated to one sponsor.
Please, keep in mind that this is a Freelance opportunity for approximately 0.7 FTE with sites in both Germany and Switzerland.
Key Responsibilities
Monitor clinical trials on-site and remotely in accordance with TFS/client SOPs, FDA regulations, and GCP/ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy; generate queries to resolve data issues
Identify site problems or deficiencies and report them to management through trip reports, memos, and communication with the Project Manager or Lead CRA
Initiate corrective actions as directed by the supervisor
Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager
Participate in contract handling and negotiation under direction of the Lead CRA/Project Manager
Set up the Investigator Site File (ISF) and Study Master File (SMF), or support the CTA in doing so, and distribute materials to investigational sites
Collaborate with the study team on SMF maintenance
Order, ship, and reconcile clinical investigational supplies for study sites, if applicable
Coordinate ordering and shipment of study supplies to sites
Prepare and submit status reports as directed by the Lead CRA/Project Manager
Review and support site staff in maintaining the SMF
Review Informed Consent Forms for essential elements and protocol compliance
Update CTMS with site and study information
Audit data in tables and text of clinical summaries (as applicable)
Qualifications:
Bachelor’s degree, preferably in life sciences or nursing, or equivalent
Experience in Medical Devices
Solid understanding of Good Clinical Practice (GCP) regulations and ICH guidelines
Ability to work independently and within a team/matrix organization
Excellent written and verbal communication skills
Strong organizational skills
Ability and willingness to travel
Experience with Medical Device submissions in both Germany and Switzerland is mandatory.
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfactionBy aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.
weniger ansehen About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
The Site Relationship Manager (SRM) covers multiple indications within the assigned country throughout the full life cycle of the trial. The key focus areas are to facilitate optimal clinical trial set-up, execution, and quality by: understanding the local environment, creating and maintaining strong, long-term relationships with sites, supporting applicable Sponsor Teams in CRO and Sponsor site oversight activities.
As part of our SRS/FSP team, you will be dedicated to one sponsor.
Please, keep in mind that this a freelance opportunity at around 0.7 FTE.
Key Responsibilities:
Understanding the Local Environment
Gain knowledge of the assigned region (treatment standards, healthcare system, regulatory environment, KOLs, site capabilities, etc.).
Support development of country-specific plans to engage advocacy groups and enhance recruitment.
Attend local medical/support group meetings and conferences.
Collaborate with internal teams and CROs to ensure quality feasibility data and effective site selection.
Provide input on site-level recruitment targets and strategies.
Understand and support compliance with local regulatory and ethics requirements.
Creating and Maintaining Strong Site Relationships
Build and maintain strong relationships with site personnel to enable timely trial delivery.
Conduct motivation visits to encourage engagement and recruitment.
Partner with internal teams, CRO CRAs, and sites to understand patient pathways and improve recruitment.
Risk Management and Communication
Identify and mitigate site-level issues proactively, sharing best practices and managing requests.
Keep internal stakeholders informed of site performance and developments.
Oversight of CRO and Site Activities
Collaborate with CRO counterparts to align strategies and attend regular local/global meetings.
Support achievement of database lock milestones with CRO CRAs and internal teams.
Share site insights, escalate issues, and contribute to mitigation plans.
Oversee CRO monitoring to ensure quality, compliance, and adherence to protocols and GCP.
Conduct Monitoring Oversight Visits to assess performance.
Review site metrics and follow up on identified concerns.
Qualifications:
Bachelor’s or Master’s degree in Life Sciences.
Minimum 7 years of experience in the pharmaceutical or clinical research industry.
At least 5 years of experience as a Clinical Research Associate, Monitor, or similar role.
Proven clinical research and site management experience within Pharma, Biotech, or CRO settings.
Direct experience collaborating with investigator sites and investigators.
Strong knowledge of ICH GCP guidelines.
Demonstrated ability to build and maintain site relationships both in-person and remotely.
Excellent networking, communication, and problem-solving skills.
Experience in rare diseases and endocrinology
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
weniger ansehen About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
The Site Relationship Manager (SRM) covers multiple indications within the assigned country throughout the full life cycle of the trial. The key focus areas are to facilitate optimal clinical trial set-up, execution, and quality by: understanding the local environment, creating and maintaining strong, long-term relationships with sites, supporting applicable Sponsor Teams in CRO and Sponsor site oversight activities.
As part of our SRS/FSP team, you will be dedicated to one sponsor.
Please, keep in mind that this a freelance opportunity at around 0.7 FTE.
Key Responsibilities:
Understanding the Local Environment
Gain knowledge of the assigned region (treatment standards, healthcare system, regulatory environment, KOLs, site capabilities, etc.).
Support development of country-specific plans to engage advocacy groups and enhance recruitment.
Attend local medical/support group meetings and conferences.
Collaborate with internal teams and CROs to ensure quality feasibility data and effective site selection.
Provide input on site-level recruitment targets and strategies.
Understand and support compliance with local regulatory and ethics requirements.
Creating and Maintaining Strong Site Relationships
Build and maintain strong relationships with site personnel to enable timely trial delivery.
Conduct motivation visits to encourage engagement and recruitment.
Partner with internal teams, CRO CRAs, and sites to understand patient pathways and improve recruitment.
Risk Management and Communication
Identify and mitigate site-level issues proactively, sharing best practices and managing requests.
Keep internal stakeholders informed of site performance and developments.
Oversight of CRO and Site Activities
Collaborate with CRO counterparts to align strategies and attend regular local/global meetings.
Support achievement of database lock milestones with CRO CRAs and internal teams.
Share site insights, escalate issues, and contribute to mitigation plans.
Oversee CRO monitoring to ensure quality, compliance, and adherence to protocols and GCP.
Conduct Monitoring Oversight Visits to assess performance.
Review site metrics and follow up on identified concerns.
Qualifications:
Bachelor’s or Master’s degree in Life Sciences.
Minimum 7 years of experience in the pharmaceutical or clinical research industry.
At least 5 years of experience as a Clinical Research Associate, Monitor, or similar role.
Proven clinical research and site management experience within Pharma, Biotech, or CRO settings.
Direct experience collaborating with investigator sites and investigators.
Strong knowledge of ICH GCP guidelines.
Demonstrated ability to build and maintain site relationships both in-person and remotely.
Excellent networking, communication, and problem-solving skills.
Experience in rare diseases and endocrinology
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
weniger ansehen About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
As VP Pathology, you will lead the strategic and operational direction of the pathology function, ensuring scientific excellence, quality, and compliance. You’ll guide a growing team, build strong client and cross-functional partnerships, and drive innovation in diagnostic and research pathology.
Key Responsibilities
Qualifications:
Advanced degree (MD, DVM, or PhD) in Pathology or Life Sciences. 10+ years of experience in pathology within a CRO, pharma, or diagnostic environment. Proven leadership of scientific and operational teams. Strong knowledge of GxP, GLP, and ISO frameworks. Excellent communication, stakeholder management, and strategic thinking skills. Fluent English; additional languages are a plus.What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
