Jobs at TFS HealthScience

Supports clinical trial execution by maintaining essential documentation and eTMF quality, coordinating study meetings and communications, tracking study information in CTMS and EDC systems, assisting with ethics and regulatory submissions, and supporting operational, budget, audit, and inspection-readiness activities. Requires clinical operations experience, knowledge of GCP and ICH-GCP, strong organizational and communication skills, and fluency in English and Swedish.

Leads and coordinates clinical study start-up activities from award through site activation. Responsibilities include developing timelines, managing ethics and regulatory submissions, supporting site feasibility and activation, coordinating clinical trial agreements, maintaining Trial Master File documentation, monitoring metrics, mitigating risks, and supporting process improvement, proposals, and business development.

Partner with senior leaders on organizational development, talent management, workforce planning, succession, performance, restructuring, employment law, and labor relations. Advise leaders, support organizational change, develop leadership capabilities, and strengthen the employer brand. The role also contributes to modernizing HR through data, digital tools, and AI in an international pharmaceutical and biotech research environment.

Manage country and site clinical operations for ophthalmology studies: oversee CRAs, ensure protocol/ICH‑GCP compliance, maintain TMF/CTMS quality, liaise with sponsors, support study planning and site performance.

Provides part-time coordination and oversight of global clinical trial supplies. Responsibilities include reviewing IMP documentation, forecasting drug needs, managing inventory and distribution planning, coordinating depots and vendors, identifying shortages or compliance risks, and maintaining inspection-ready records in accordance with GxP requirements.

Provides operational and project coordination support for global clinical trials. Responsibilities include maintaining CTMS and study records, coordinating documentation and meetings, tracking deliverables, supporting vendors and budgets, assisting with regulatory submissions and audits, maintaining TMF and ISF files, coordinating study supplies, and facilitating communication among sponsors, sites, vendors, and cross-functional teams.

Provides statistical programming expertise for global clinical studies at a CRO. Develops and validates SAS programs, SDTM and ADaM datasets, and Tables, Listings, and Figures. Reviews clinical data, statistical outputs, protocol deviations, and external partner deliverables while supporting regulatory submissions and inspection readiness. Collaborates with Biostatistics, Clinical Operations, and Data Management teams and contributes to programming standards, documentation, automation, and continuous improvement.

Drive sales and business development for life science consulting, staffing, resourcing, and FSP solutions across Sweden and the Nordic region. Generate pipeline, win new customers, manage the full sales cycle, negotiate agreements, develop accounts, and achieve revenue targets. Manage consultants assigned to customers, including onboarding, performance, development, and salary discussions. Build relationships with pharmaceutical, biotech, medtech, CRO, and clinical research organizations.

Coordinates hospital-based clinical trial activities during patient recruitment, including monitoring patient flow, identifying eligible participants, scheduling study visits, coordinating protocol activities, collaborating with investigators and hospital staff, and supporting documentation and data collection. The role requires regular on-site presence in Sweden and runs at approximately 0.3 FTE through April 2027.

Leads European and global regulatory strategy for drug, device, and combination-product clinical development. Supports RFPs, bid defenses, country startup intelligence, EMA and national scientific advice, Pediatric Investigation Plans, orphan designations, PRIME, and regulatory systems. Collaborates with US regulatory teams, clinical development functions, senior management, and customers while ensuring compliance with SOPs, laws, and regulations.

Lead functional and project-level quality oversight for clinical projects. Ensure GCP/GxP compliance, manage eQMS activities and system validation oversight, handle vendor qualification and CAPA investigations, generate and approve controlled documents, and support risk management and client-facing quality frameworks.

Principal Data Manager talent community candidate responsible for clinical data management across late-phase, observational, and interventional studies. The role requires oversight of vendors and stakeholders, ensuring data quality, regulatory compliance, and process improvement. Candidates should have experience in CRO, biotech, or pharmaceutical environments, knowledge of CDISC, GCP, ICH guidelines, and regulatory requirements, and proficiency with EDC systems such as Medidata Rave or Inform.

Serves as Italy’s local pharmacovigilance representative and primary liaison with AIFA and the EU QPPV. Supports regulatory interactions, responses to authority requests, adverse-event collection and escalation, safety-information transfers, case follow-up, and maintenance of local pharmacovigilance procedures. Ensures compliance with Good Pharmacovigilance Practices, national regulations, corporate procedures, and applicable clinical research requirements while communicating regulatory updates.

Coordinates and oversees bioanalytical and central laboratory activities for oncology clinical trials. Responsibilities include vendor and laboratory oversight, sample shipments, biobanking, biosample and biomarker management, laboratory documentation, protocol contributions, and stakeholder coordination across study teams and external providers.

Leads global oncology clinical research projects from planning through delivery, ensuring milestones, budgets, quality standards, regulatory compliance, and client expectations are met. Manages multidisciplinary study teams, project risks, resources, vendors, financial performance, communications, and escalations. Provides mentorship and oversight to Project Managers, supports bid defenses and business development, and contributes to clinical operations improvements and procedural development.

Supports global HR operations across the employee lifecycle, including onboarding, offboarding, documentation, employee records, learning initiatives, student and intern administration, communications, reporting, and process improvement. The trainee collaborates with international HR teams, uses digital tools, and gains practical experience while completing studies.

Conducts independent on-site and remote monitoring of ophthalmology clinical trial sites, including unmasked monitoring, investigational product accountability, informed consent and protocol compliance review, source documentation and CRF verification, TMF and ISF maintenance, and CTMS updates. The role supports audits, inspections, site supplies, monitoring plans, project tracking, and CRA mentoring while ensuring participant safety, data integrity, and regulatory compliance. Based in Denmark, the freelance role requires travel of up to 60–80%, including overnight and international travel.

Conducts independent on-site and remote monitoring of clinical trial sites, including initiation, monitoring, and closeout. Ensures participant safety, informed consent, protocol compliance, data integrity, investigational product accountability, and accurate clinical documentation. Maintains site files and tracking systems, reports findings, supports audits and inspections, and collaborates with sponsors, investigators, and study teams. The role may mentor CRAs, support project activities, and deliver therapeutic-area training for ophthalmology studies.

Conducts independent on-site and remote monitoring of ophthalmology clinical trials, including site initiation, monitoring, closeout, protocol compliance, informed consent, source documentation, CRF review, investigational product accountability, and regulatory compliance. Maintains trial documentation and site systems, reports findings, supports audits and inspections, and may assist with project tracking, monitoring plans, CRA resource management, training, and mentoring. Requires extensive monitoring experience, unmasked CRA expertise, and willingness to travel 60–80%.

Conducts on-site and remote monitoring of ophthalmology clinical trial sites, including initiation, monitoring, and closeout. Ensures participant safety, protocol compliance, data integrity, informed consent, investigational product accountability, and proper site documentation. Maintains CTMS and eTMF records, prepares monitoring reports, supports audits and inspections, and collaborates with sponsors and study teams. May assist with project tracking, monitoring plans, CRA mentoring, training, and assessment site visits.