Clinical Data Manager
- Employer
- Proclinical Staffing
- Location
- Zug, Switzerland
- Salary
- £60000 - £61000 per annum
- Start date
- 19 Apr 2021
- Closing date
- 3 May 2021
View more
- Discipline
- Data Management / Statistics, Clinical Data Management
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
Job Responsibilities Oversee all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)Creation of essential documents (DMP, UAT documents)Creation of submission ready clinical data package per regulatory agencies requirements.Creation of archival package of clinical data per requirementsOversee all activities related to Data Management:Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data producedFacilitate cross-functional review by applicable stakeholders of essential documents and data management deliverablesKeep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases (such as for DSMB/IDMC, interim and final locks, updates after lock) as per plan and blinding rules.Participate in User Acceptance Testing Activities for the applicable Data Collection ToolsPerform adequate Quality Control for data completeness and accuracyContribute to the development in lessons learned and shares best practices within the trial and department.The CDM will also participate in activities other than study-related: Skills and Requirements We are looking for people with extensive data management experience (more than 5 years for sure)More than 4 years of experience in project management applied to data managementAlso, ability to negotiate budget (financial skills), being a primary point of contact for DM activities in front of the clientAttending and preparing bid defences and kick of meetings, participating in internal and external audits, is a must To ApplyProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.#LI-SB1
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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