Clinical Data Manager to Oncopeptides
Poolia Life Science & Engineering AB / Elkraftsjobb / Stockholm
2019-05-21
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hela Sverige Oncopeptides, an innovative pharmaceutical company developing drugs for the treatment of cancer, are now looking to hire a Clinical Data Manager that will be responsible for ensuring planning and execution of Data management (DM) deliverables in allocated clinical studies. This is a chance for you to join an exciting, expanding company and a dedicated team.
The position is full time and based in central Stockholm at Luntmakargatan. We will interview candidates continuously and welcome your application today.
JOB DESCRIPTION
As Clinical Data Manager, you will be responsible for ensuring planning and execution of Data management (DM) deliverables in allocated clinical studies. The Clinical Data Manager will, in close collaboration with CRO vendors, have overall accountability for DM activities and deliverables to ensure high quality data. You will be responsible for the oversight of DM tasks delegated to CRO vendors and will support the development and optimization of internal study processes and tools. The Data Management team is currently consisting of 3 members and you will be reporting to the Data Management Director. You will work closely with the Clinical team.
The key responsibilities includes but are not limited to:
• Planning of all data management activities across all phases of study conduct
• Provide strategic data management expertise to clinical study teams
• Performing CRO DM oversight to ensure CRO DM deliverables are performed in compliance with the agreed scope of work, protocol, ICH-GCP, regulatory requirements and relevant SOPs
• Accountability for all end-to-end DM deliverables for allocated studies within the agreed timelines and expectations
• Actively drive and contribute to development of program and study level data management processes and guidelines including SOP writing, implementation of new systems and processes and project data standards
• Performing quality control of internal DM documentation
• Support build up and overview of data in an internal Data Warehouse project
QUALIFICATIONS
To fit the role you have a Bachelor of Arts or a Bachelor of Science degree or equivalent, preferably within science. You have a minimum of 3-5 years of experience as a data manager in the pharmaceutical/CRO industry and proven leadership and Project Management Skills and experience as a main study Data Manager. Fluent written and spoken English is a prerequisite.
Further qualifications includes:
• Knowledge of clinical studies and the drug development process
• Experience conducting and securing oversight of studies and/or projects; DM vendor oversight of oncology studies an advantage
• Knowledge of medical terminology
• Strong understanding of GCPs, SOPs, regulatory requirements and Good Data Management Practices
• Experience with data management systems
o Solid knowledge of CDISC (CDASH, SDTM, ADaM, define.xml)
o Data visualization software for data review and study oversight (e.g. J-Review, Spotfire, Qlik Sense, etc.)
The right candidate has solid communication skills and a flexible mindset. You have strong team working skills and the ability to cooperate with colleagues at Oncopeptides as well as external partners. Further you are well organised, analytical and have a pragmatic approach. You are friendly, positive, and fun to work with and you enjoy working in a fast paced, changing and time sensitive environment.
ONCOPEPTIDES
Oncopeptides is a pharmaceutical company developing drugs for the treatment of cancer. The company is focusing on the development of the lead product candidate melflufen, a novel lipophilic peptide-conjugated alkylator, belonging to a new class of drugs called Peptidase Enhanced Cytotoxics (PEnC). Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in a global pivotal phase 3 trial called OCEAN, a phase 2 trial called HORIZON and in two additional supporting clinical trials. Oncopeptides' headquarters is located in Stockholm, Sweden and the company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-05-21ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-06-09
Ange följande referens när du ansöker: 53612
Klicka på denna länk för att göra din ansökanKontaktSara Jupiter
sara.jupiter@poolia.se 073-0965315
FöretagPoolia Life Science & Engineering AB
AdressPoolia Life Science & Engineering AB
Box 207
10124 Stockholm
KontorsadressBox 207
Jobbnummer 4802542
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