Job description

🎯 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.

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