Lediga jobb LINK Medical Research AB i Malmö

This position is open at our office in Stockholm, Uppsala and Malmö, Sweden.
LINK Medical is searching for a Group Manager Medical Writing (MW). Our company is growing, and the portfolio of cross-functional projects is increasing. As a Group Manager MW, you will work in close collaboration with members of several project teams (i.e. project managers and statisticians)
across the LINK Medical organization. The position might require to be partly outsourced to clients in the greater Stockholm, Uppsala and Malmö area.
Responsibilities:
Line management of the assigned staff (3-5 MWs), to keep oversight of resourcing, recruitment, training, MW processes and department budget.
The role also entails work as a medical writer (approx. 50%). This means coordination, writing, editing and quality control of documents for clinical trials such as clinical study protocols, informed consent forms, safety summaries, clinical study reports and scientific publications.

Desired qualifications:
Natural science/medicine degree at a university level
A doctoral title and previous line management experience is meritorious.
Generally good IT skills and use of standard office tools
Fluent in Swedish and English (spoken and written)
Previous experience from working with clinical trials from the pharmaceutical industry, CRO, or similar activities
Used to writing and summarizing scientific documents and evaluating information from statistical analyses in the form of tables and figures.

Personal characteristics
As a person, you are flexible, structured, effective and customer-focused
You create good relationships with customers and staff
You take initiatives acting with confidence and work independently
You write in a well-structured and logical way to meet the needs of the audience


LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive compensation and benefits scheme for all employees.
Contact information:
If you would like to know more or have any questions about the position, please contact VP Clinical Operations, Johanna Sundberg [email protected], +46 70 810 14 42
All applications are treated confidentially. Local applicants will be prioritized.
Last day for application: 2020-08-21
Please apply to the job by filling out the application below: Visa mindre

This position is based at any of our offices in Sweden (Stockholm, Malmö, Uppsala).
Do you want to join a growing company with a portfolio of cross-functional projects and be part of amazing, new, and innovative projects at LINK Medical?
As a Senior Biostatistician, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas. We offer a variety of stimulating and challenging responsibilities in a friendly team made of statisticians and programmers who focus on collaboration and sharing of experience. We work in an open and flexible environment.
Responsibilities
Responsible for statistical activities within clinical studies (e.g. statistical input to protocols, sample size calculations, generation of randomization lists, writing statistical analysis plans, interpretation of statistical analysis results, producing statistical reports and contributing to clinical study reports)
SAS programming of statistical analyses in clinical studies
SAS programming of analysis datasets in clinical studies
Mentoring of less experienced biostatisticians
Supporting the business development department in bid defense meetings and customer contacts
Development and adaptation of processes within the biometrics department


Desired qualifications
MSc in statistics or mathematical statistics or similar field
Minimum 5 years of experience in statistics within clinical trials
Experience of SAS programming in clinical trials
Fluent in English
Generally good IT skills and use of standard office tools

Helpful but not required
Experience from statistics within oncology
Experience from biostatistical advice for clinical study designs
Knowledge in CDISC standards
Experience from real world evidence projects

Personal characteristics
Service-minded with good collaboration and communication skills
Well organized and structured, able to work both independently and in teams
Team player, flexible, accountable and solution-oriented


LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience, and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams, and the authorities. We offer a competitive compensation and benefits scheme for all employees. Visa mindre

This position is open at our office in Malmö, Stockholm/Uppsala Sweden.
LINK Medical is searching for a CRA. Our company is growing, and the portfolio of cross-functional projects is increasing. As a CRA, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas. The position might require to be outsourced to clients in the greater Malmö and Stockholm/Uppsala area.
Responsibilities
Complete clinical monitoring and site management tasks according to ICH-GCP, and applicable regulations, timelines, agreements and budget
Manage and perform monitoring and site management activities related to clinical trials of all phases (I-IV) and in all stages:
Planning
Initiation/Set-up
Conduct
Close-out
Plan and organize investigators’ meetings
Complete or contribute to EC/IRB and CA applications
Training of study staff and other LINK Medical employees
Develop training material and conduct internal and external courses

Desired qualifications
Natural science degree at college/university level
Generally good IT skills and use of standard office tools
Fluent in Swedish and English
Up to date on ICH-GCP including national regulatory requirements
Significant experience in monitoring studies and investigator site management
Experience in Oncology as well as in other therapeutic areas

Personal characteristics
Service minded with good cooperation and communication skills, as well as oral and written presentation skills
Well organized and structured, able to work both independently and in teams
Independent, flexible, accurate and solution oriented



LINK Medical offers
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive salary, pension and insurance scheme and a bonus scheme for all employees. Visa mindre

The position is open at our office in either Stockholm (Kista) or Malmö, Sweden.
LINK Medical is searching for a Safety Manager. Our company is growing, and the portfolio of cross-functional projects is increasing. As a Safety Manager, you will work in close collaboration with members of several project teams and members of the Safety Group across the LINK organization. The position might require to be outsourced to clients in close proximity to your home.


Responsibilities
As a member of the Nordic Safety team at LINK you will take part in cross-functional and cross-national pharmacovigilance activities for international project including activities such as acting as the QPPV/dQPPV, set-up of PV system, writing the PSMF and PV SOPs
Write RMPs in collaboration with e.g. medical advisors
Write PSUR, DSURs and other safety documents
Perform signal detection/management including data collection, data assessment and evaluation in collaboration with e.g. medical advisors
Handling of safety in clinical trials
Handling of SAE in clinical trials and spontaneous reports from the market
Review and write the safety section in clinical study protocols incl review of IBs from a safety perspective
Literature search
Electronic reporting to EudraVigilance
Medical information handling such as being the first point of contact during office hours for receiving, handling and providing responses to medical enquiries (from customers, patients and HCPs including pharmacies) on marketed products
Updating of templates for safety handling in specific studies/projects according to relevant SOPs
Provide internal support to other relevant departments
Involved in improvement projects with other relevant departments
Being well-informed and updated on laws, directives and guidelines concerning safety handling

 
Desired qualifications
Minimum Bachelor’s degree, preferably in life science or nursing; or equivalent
At least 2-3 years’ experience within pharmacovigilance
Ability to show initiative
Ability to work independently
Ability to work in a fast-paced environment with changing priorities
Knowledge about pharmaceuticals and biotech products and to understand the medical terminology and science associated with the assigned drugs and therapeutic areas
Fluent in Swedish and English (written and oral)

 
Personal characteristics
Service minded with good cooperation and communication skills, as well as oral and written presentation skills
Well organized and structured, able to work both independently and in teams
Independent, flexible, accurate and solution oriented

 
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive salary, pension and insurance scheme and a bonus scheme for all employees. Visa mindre