Life Sciences BA Generalist (Contractor) Job in Remote | Binariks

Binariks | IT services

1h 9m ago

Worldwide Remote

Part Time

We are looking for a Life Sciences BA Generalist (Contractor) with strong experience in the pharmaceutical and life sciences industries to join our Solution Group as domain expert. In this part-time role, you will support presales and discovery activities, helping shape solutions that address client needs and align with industry-specific requirements.

What We’re Looking For:

Business Analysis / Product Ownership: Experience as a Business Analyst or Product Owner working on software for pharmaceutical companies, biotech organizations, or Contract Research Organizations (CROs)
Presales and Discovery: Experience in solution scoping, effort estimation, and proposal development
Regulated Environments: Experience working in a GxP-regulated environment, with an understanding of GCP, FDA 21 CFR Part 11, audit trails, validation, and ALCOA+ data integrity principles
Hands-on experience in at least one of the following areas: Clinical Operations (CTMS, eTMF, feasibility, patient recruitment, and RBQM); Clinical Data (EDC, eCOA/ePRO, IRT, and clinical data management); Real-World Data & Evidence (RWD/RWE); Pharmacovigilance / Drug Safety; Regulatory Affairs & Labeling; Quality Systems (eQMS); Manufacturing & Supply (GMP, MES, and serialization); R&D & Laboratory Informatics (LIMS and ELN); Commercial Systems & Patient Services
Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams
English: Upper-Intermediate or higher

Responsibilities:

Play a key role in presales activities, supporting solution design and client engagements
Ensure proposed solutions and processes align with applicable regulatory requirements and industry best practices
Identify client business needs, expectations, and challenges, translating them into clear business drivers and effective technical solutions
Plan, conduct, and facilitate discovery workshops with clients and stakeholders
Elicit, analyze, simplify, prioritize, and document business requirements
Drive and coordinate discovery-phase activities, ensuring alignment between business needs and proposed solutions

Will Be a Plus:

Life Sciences Platforms: Hands-on experience with Medidata, Veeva, Oracle Health Sciences, or IQVIA solutions
Medical Devices / SaMD: Experience with regulated medical device software, including Software as a Medical Device (SaMD), or medical devices used in clinical trials
Healthcare Interoperability: Experience with healthcare data exchange standards such as HL7 and FHIR, particularly in integrating EHR data into clinical trial systems

Required Languages

🇬🇧 English

What We’re Looking For:

Business Analysis / Product Ownership: Experience as a Business Analyst or Product Owner working on software for pharmaceutical companies, biotech organizations, or Contract Research Organizations (CROs)

Presales and Discovery: Experience in solution scoping, effort estimation, and proposal development

Regulated Environments: Experience working in a GxP-regulated environment, with an understanding of GCP, FDA 21 CFR Part 11, audit trails, validation, and ALCOA+ data integrity principles

Hands-on experience in at least one of the following areas: Clinical Operations (CTMS, eTMF, feasibility, patient recruitment, and RBQM); Clinical Data (EDC, eCOA/ePRO, IRT, and clinical data management); Real-World Data & Evidence (RWD/RWE); Pharmacovigilance / Drug Safety; Regulatory Affairs & Labeling; Quality Systems (eQMS); Manufacturing & Supply (GMP, MES, and serialization); R&D & Laboratory Informatics (LIMS and ELN); Commercial Systems & Patient Services

Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams

English: Upper-Intermediate or higher

Responsibilities:

Play a key role in presales activities, supporting solution design and client engagements

Ensure proposed solutions and processes align with applicable regulatory requirements and industry best practices

Identify client business needs, expectations, and challenges, translating them into clear business drivers and effective technical solutions

Plan, conduct, and facilitate discovery workshops with clients and stakeholders

Elicit, analyze, simplify, prioritize, and document business requirements

Drive and coordinate discovery-phase activities, ensuring alignment between business needs and proposed solutions

Will Be a Plus:

Life Sciences Platforms: Hands-on experience with Medidata, Veeva, Oracle Health Sciences, or IQVIA solutions

Medical Devices / SaMD: Experience with regulated medical device software, including Software as a Medical Device (SaMD), or medical devices used in clinical trials

Healthcare Interoperability: Experience with healthcare data exchange standards such as HL7 and FHIR, particularly in integrating EHR data into clinical trial systems