Senior Data Manager Europe Based (Remote)

Location: Any of the Company’s offices in Europe (or remote)

We are open to receiving applications no matter your current location as the position can be based in any of the Company’s offices in Europe.

Who are we?

Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations.

With 26 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.

In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.

We are looking for a Senior Data Manager to join our Data Management team and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

What do we offer?

• Working in a successful company that’s growing and changing every day
• Working with a highly experienced team of the clinical research professionals
• International projects and professional growth
• Performance bonus
• Referral bonus
• Training opportunities
• Work from home
• Flexible work hours

Who are we looking for?

Qualifications and Experience

• BS or higher degree in a biomedical or technical discipline (ex. Biology, Biochemistry, Biostatistics, Mathematics, Informatics, or Enginery
• At minimum 5 years of previous experience in similar positions
• Familiar with the life science market in general
• Experience in pharmaceutical development processes
• Excellent written and oral English communication skills
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to communicate effectively with appropriate internal and external contacts
• Ability to work on multiple projects and manage project timelines
• Good organizational and time management skills and initiative
• Good communication and presentation skills
• Computer literacy

Your responsibilities

• 
  Create key data management documents including but not exclusive to:

• Case Report Form
• Data Management Plan
• Data Management Report
• Data Validation Plan

• 
  Support all data cleaning activities for assigned projects
• 
  Write specifications for the set-up and modification of electronic data capture systems and other clinical databases
• 
  Perform verification and User Acceptance Testing of electronic data capture systems and other clinical databases
• 
  Create and review CRF and eCRF completion guidelines, EDC system manuals and access instructions
• 
  Define, write and validate Manual and Automatic edit checks for clinical data cleaning
• 
  Specify and review patient listings/tables for clinical data cleaning
• 
  Set-up processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory) in collaboration with Safety internal and external departments
• 
  Liaise with Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstanding
• 
  Liaise and collaborate with corresponding teams in other departments working on the same project
• 
  Train other project team members to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data
• 
  Produce information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor
• 
  Liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees, Data Safety Monitoring Committees, or any other third parties involved in data management activities
• 
  Develop and maintain relevant report metrics to share with the overall study team and upper management
• 
  Support other departments with additional ad-hoc tasks such as preparation of newsletter, CRA training, etc.
• 
  Apply company standards, and actively participating in improvements towards harmonization and standardization across projects
• 
  Maintain and expand the knowledge base in the area of expertise. To attend courses to develop and keep skills and knowledge current. To comply with continuing education requirements

By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.