Clinical Data Manager/Senior Clinical Data Manager

We are hiring a Clinical Data Manager/Senior Clinical Data Manager (depending on level of experience) to join our team, based in any of the following countries: UK, Spain, France, Italy, Netherlands, Belgium, Germany, Hungary, Slovakia, Serbia, Romania or Poland.

Depending on the level offered you may lead all aspects of the clinical trial data management process from study start up to post database lock for assigned Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed.

Oversee and/or perform database development and testing.

 

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.

 

• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing

 

• May perform quality control of data entry

 

• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.

 

• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders

 

• May assist in building clinical databases

 

• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.

 

• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications

 

• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.

 

• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.

 

• Review and query clinical trial data according to the Data Management Plan

 

• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM

 

• Run patient and study level status and metric reporting

 

• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency

 

• Coordinate SAE/AE reconciliation

 

• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables

 

• May assist with SAS programming and quality control of SAS programs used in the Data Management department

 

• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

 

• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project

 

• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities

 

• May attend strategy meetings, bid defence prep meetings, bid defences, capability presentations, potential client engagement meetings

 

• May review Request for Proposals (RFP), proposals, provide project estimates

 

• Provide leadership for cross-functional and organization-wide initiatives, where applicable

 

• Trains and ensures that all data management project team members have been sufficiently trained

 

• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

 

• May present software demonstrations/trainings, department/company training sessions, present at project meetings

 

• May require some travel

 

• Perform other duties as assigned

 

Qualifications:

Minimum Required:

Bachelors degree or in country local equivalent or equivalent related experience

 

Other Required:

Clinical Data Management experience utilizing various clinical database management systems

Broad knowledge of drug, device and/or biologic development and effective data management practices

Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook

Excellent organizational, interpersonal & leadership skills

Professional use of the English language; both written and oral

Ability to travel (nominal expected)

Candidates must be eligible to work in UK/EU.

 

Preferred:

Experience in a clinical, scientific or healthcare discipline

Understanding of CDISC standards (CDASH, SDTM, etc.…)

Academic concentration in one or more of the following, or related discipline; life sciences, computer science, or engineering. Advanced degree in clinical data management, health informatics, biometrics or similar.

 

Precision medicine is revolutionizing the attack on cancer and rare diseases—and we are passionate about helping you harness its power. We strike tumours on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

Why should you consider joining us? Because Precision for Medicine is not your typical CRO. As a member of our thriving team, opportunities to work with leading subject matter experts who understand the patient mindset and experience will surround you. We help translate science into success for patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who tackle unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first. We focus in an environment where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community.

We welcome your voice and opinions and provide you with the ability to truly make an impact on investigational product development. Are you ready to be part of a close-knit clinical trial team that is passionate about saving the lives of patients every single day? Then look no further, we’d like to help you take your career to the next level. If the duties sound like a fit, we’d love to hear from you!

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