Business Analyst GxP
3 tygodni temu
Join Natek as a Business Analyst and help our customer to digitalize clinical trials for patients, healthcare professionals, and sponsors. We aim to optimize clinical trial design and delivery through a suite of digital solutions that support traditional, decentralized, and hybrid trials. By unifying complex trial processes into a single digital platform, we make participation simpler for patients, more efficient for clinical staff, and fully compliant for sponsors.
Your responsibilities
Conduct business analysis activities for onboarding clinical studies into a digital clinical trial platform.
Translate clinical study protocol requirements (SOA) into technical specifications for system configuration.
Collaborate with cross-functional teams, including clinical research associates (CRAs), doctors, and IT teams, to ensure seamless system implementation.
Define and implement standards for business analysis and clinical trial processes within the platform.
Prepare, review, and analyze analytical and functional documents such as URS (User Requirements Specifications) and CS (Configuration Specifications).
Present and demonstrate the system to stakeholders, including training and demo sessions.
Support integration of various medical devices and remote patient monitoring (RPM) tools with the digital platform.
Manage small teams or project workstreams as needed.
Our requirements
Senior experience in the pharmaceutical industry with knowledge of clinical trial processes, regulations, and GxP compliance.
Experience working with clinical trial management applications and digital platforms (e.g. Veeva, RTSM systems like CUBE or Calyx, EDC Rave, Labcorp).
Strong understanding of eCOA and other clinical questionnaires (ClinRO, SPFQ) and ability to map patient response data to client databases.
Proficiency in MS Excel, SharePoint, Word, Confluence, Jira, and GitHub.
Ability to prepare and analyze documentation, including functional specifications and configuration specifications for digital platforms.
Experience running system demos and training sessions for stakeholders.
Knowledge of mobile and web applications for patients, doctors, and CRAs.
Strong analytical, organizational, and communication skills.
You will be preferred if you have:
Experience with remote patient monitoring (RPM) solutions.
Our offer
Flexible type of employment (COW OR B2B)
Internal Mobility Program – enjoy many opportunities for career growth, job rotations, diversity of projects & technologies
International, diverse, and inclusive working environment – get experience in global projects for worldwide leaders and enjoy multinational teams
Referral Program – enjoy cooperation with your colleagues and get the bonus
5/10 years NATEK club – we offer long term cooperation and celebrate each fifth year cooperation anniversary with gifts
NATEK CSR Events & team buildings – enjoy our values: accountability, partnership and expertise and #workITwithus
Education – benefit from our know how, learning courses and certificates and IT events – be part of community of leaders of the industry and take part as a speaker or a visitor
Relocation Bonus – reimbursement for moving expenses for out-of-town candidates
Bonuses for Personal Events – we congratulate you important events of your life: giving birth to children, university graduation, etc.
MyBenefit (Cafeteria) – use our e-shop with corporate benefits like travel, theater tickets, books etc.
Additional Medical health care – on top of standard health insurance
Multisport Club Card
Technical and Personal training – we are investing in your skills growth
Language courses
1 paid day off for volunteering – we are supportive in all charity ideas
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