Clinical Data Manager to Oncopeptides

Do you have experience in clinical trial data management? Are you looking for an opportunity to be part of an entrepreneurial and innovative company in the pharmaceutical industry?

Oncopeptides is looking to recruit a Clinical Data Manager to join the company. As a Clinical Data Manager, you will have an important role where you will be responsible for planning and execution of data management deliverables in clinical studies from the Sponsor side.

Oncopeptides is a science-driven, entrepreneurial company committed to introducing new medicines for patients with diseases where there are clear unmet needs. We have a values-driven culture and an inclusive organization that welcomes people with different backgrounds and perspectives. Your skills and experience within clinical data management will make a valuable difference for our patients and you will be collaborating with a team of dedicated, highly competent and friendly colleagues as well as external collaborators. If this sounds interesting to you - come join us!

 This is a recruitment for a permanent position at the Stockholm office and in this role you will report to the Chief Operating Officer. We evaluate candidates continuously and we welcome your application today.

RESPONSIBILITIES

As Clinical Data Manager, you will have overall accountability for data management activities and deliverables, to ensure high quality study data. This includes being responsible for the oversight of any data management tasks delegated to CRO and EDC vendors, or personally performing such activities depending on the study and its level of outsourcing.  You will work in close collaboration with the rest of the Sponsor study teams in your allocated studies, as well as with CRO and EDC vendors. You will also support other departments within Oncopeptides such as Commercial and Market Access with your data management expertise.

Main responsibilities include:

• Plan and support data management activities in allocated studies across all phases of study conduct (planning, start up, during the study and at the end of a study)

• Participate in selection of CRO vendor

• Lead EDC vendor selection process if CRO’s proposal for EDC system is unsatisfactory

• Be the primary point of contact for the EDC vendor when applicable

• Provide strategic data management expertise to clinical study teams

• Perform oversight to ensure data management deliverables for allocated studies are executed in compliance with the agreed scope of work, protocol, ICH-GCP, regulatory requirements and relevant SOPs, within the agreed timelines and expectations

• Aid in maintaining a high data quality as a part of the sponsor oversight by being a cross-functional study team member, continuously reviewing e.g. DM plans and data deliverables from CROs which includes investigating implausible results

• 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

• Ensure data is compliant with CDISC/SDTM, which includes reviewing and approving SDTMs before finalization for a submission or any other key deliverable

• Project lead the QC process for various regulatory documents by leading a team of fact checkers, statistician, medical writer and other functions as applicable.

QUALIFIACTIONS

Key qualifications for the position include:

• University degree within a relevant field or equivalent (knowledge of science or a scientific background is preferred).

• Multiple years of experience as a data manager in the pharmaceutical/CRO industry. Experience in oncology studies is an advantage.

• Project management skills and ability to lead teams

• Understanding of Good Clinical Practice, regulatory requirements and Good Data Management Practice

• Knowledge of medical terminology

• Familiarity with CDISC data standards

• Basic or advanced skills in programming (e.g. SAS or R)

• Fluency in Swedish and English, with excellent oral and written communication skills

As a person, you are structured, result-oriented, tech-savvy and thorough. You enjoy working both independently and in team settings. Importantly, you like to unravel and find solutions to problems and challenges and want to be part of a dynamic workplace where people matter and your contributions will make a positive impact.

If you are passionate about making a difference and have the skills and experience to excel in this role, we invite you to apply today!

ABOUT ONCOPEPTIDES

Oncopeptides AB (publ) is a biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers. We are science driven, entrepreneurial, and committed to bringing innovation to our patients. Our vision is to bring hope to patients through passionate people, innovative science and transformative drugs.

Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on the Small Cap segment on Nasdaq Stockholm with the ticker ONCO.

Oncopeptides’ headquarters and laboratory are located in Stockholm, Sweden. Today the company consists of around 80 co-workers in total with a growing European organization.