Do you want to enjoy what you do – for real – every day? If the answer is yes, you think just like us. In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a difference in people’s lives – for real. Mölnlycke is a world leading supplier of disposable products and solutions that help healthcare professionals achieve the best patient-related, clinical and financial outcomes. We design and deliver products and solutions for wound care, pressure ulcer prevention and surgery. Our products and solutions are cost-effective, which is supported by both clinical and health economic evidence. We are now expanding the business and have high ambitions for the future. Do you want to be part of this exciting journey?
We are now looking for a Clinical Data Manager & Analyst (CDMA)
As Clinical Data Manager & Analyst, you are accountable for all data management and data/statistical analysis throughout the course of the trial.
You secure optimal analysis of the clinical data and you support in protocol development and report writing with relevant knowledge.
To efficiently reach your objectives you must build, manage, and maintain a network of external experts and subcontractors.
The role should cover specialist competence within global and local regulations in the area of Data Management and Analysis of clinical data.
- Accountable for the data management of (cross functional) clinical projects of various methodology.
- Accountable for the data analysis of (cross functional) clinical projects of various methodology. The role owns the outsourcing strategy, and should manage, and optimize an external network of partners (CROs/experts) to whom data management and analysis tasks can be outsourced to.
- The role will monitor and oversee DM&A resource needs and escalate as appropriate.
- Accountable for the design, methods and management of all related documentation including key documents such as Case Report Forms, Data Management Plans, Data Validation Plans, Statistical Analysis Plan and related reports.
- Accountable for data base design and all relevant programing such as EDC data export, listings, checks, derived data sets and statistics/analytics as applicable.
- Accountable for the data cleaning process including pre/post clean file activities.
- Review and update of applicable SOPs.
The various clinical projects include, but are not limited to, company/investigator sponsored studies, registry studies, pre-/post-registration studies and human healthy volunteer trials.
- Relevant (Life science) education on MSc level
- Minimum 5 years of relevant experience in clinical data management and analytics in an international setting
- Senior level of statistical knowledge
- Senior programming qualifications to design data bases and to optimise extraction and analyses of clinical data
- Computer literate and in-depth knowledge in key software’s such as SAS and MS Office (Experience from different EDC systems and data bases is an advantage)
- Solid knowledge of applicable regulations/laws
- Proven track-record in vendor management
- Proven track-record in managing all parts of clinical data management and analysis strategies
- Solid experience of DM&A of various study types.
- Basic understanding in scientific writing
- Fluent in English (written and spoken)
To be successful in this position you have a strong feeling of ownership and execution. You communicate efficiently with various stakeholders, sub-contractors and partners (CROs). You work comfortably in parallel projects, embrace change and have a solution oriented mindset.
The position is full-time and based in Gothenburg.
Selection and interviews are held continuously so send your CV and cover letter ASAP to email@example.com and no later than 15 September.
Contact Tom Bergqvist, Recruitment Partner, In-house Recruitment Services at + 46 733 872722 if you have any questions regarding this position.
We look forward to receiving your application!