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BioSpace

BioSpace

www.biospace.com

4 Jobs

144 Employees

About the Company

BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.

Listed Jobs

Company background Company brand
Company Name
BioSpace
Job Title
CLINICAL TRIAL MANAGER (CONSULTANT)
Job Description
**Job Title** Clinical Trial Manager (Consultant) **Role Summary** Provide operational expertise for one or more oncology clinical trials, overseeing start‑up, conduct, and close‑out activities. Ensure compliance with ICH/GCP and regulatory standards while managing timelines, budgets, vendors, and cross‑functional collaboration to drive successful trial execution. **Expectations** - Deliver trial milestones on schedule and within budget. - Maintain regulatory compliance and high data quality. - Manage vendor performance and contractual obligations. - Communicate risks/issues promptly and implement corrective actions. - Support site readiness, supply chain coordination, and documentation. **Key Responsibilities** - Develop operational strategies: country/site feasibility, CRO and vendor selection. - Create and monitor trial timelines, budgets, and payment tracking; flag variances. - Draft, negotiate, and maintain vendor contracts in partnership with legal/finance. - Oversee day‑to‑day vendor activities; escalate risks to study team. - Review site visit reports and maintain Trial Master File (TMF) integrity. - Track and report study metrics from start‑up through close‑out. - Coordinate investigational product release and ensure site supply of kits/lab materials. - Contribute to protocol, consent forms, eCRF, site instructions, and other study documents. - Partner with Data Management and Clinical Science to monitor data entry and resolve quality issues. - Build and sustain relationships with internal stakeholders, CROs, and external partners. - Lead study execution team meetings; support SOP development and CRO training. - Assist in preparing Investigator and Study Coordinator meetings. **Required Skills** - In‑depth knowledge of ICH/GCP and applicable regulatory guidelines (e.g., ICH/CFR). - Strong project management: timeline, budget, and risk oversight. - Vendor and CRO management experience. - Excellent written and verbal communication; ability to work cross‑functionally. - Proactive problem‑solving and independent decision‑making. - High organizational detail, prioritization, and multitasking capability. - Proficiency in Outlook, Word, Excel, PowerPoint. - Willingness to travel up to 15% (domestic & international). **Required Education & Certifications** - Bachelor’s degree in a health‑care, life‑science, or related scientific discipline. - Minimum 5 + years of clinical operations experience (7 + years overall preferred). - Demonstrated understanding of ICH/GCP; GCP certification preferred but not mandatory.
South san francisco, United states
On site
Senior
11-10-2025
Company background Company brand
Company Name
BioSpace
Job Title
Director, Corporate Counsel - Privacy / Transactions
Job Description
**Job Title:** Director, Corporate Counsel - Privacy / Transactions **Role Summary** Serve as a bridge between the Privacy Office and the Transactions Team, integrating privacy expertise into contract development and legal strategy. Provide strategic counsel on complex privacy matters across business transactions, ensuring compliance with data privacy laws and organizational policies. **Expectations** - Minimum 7 years of legal experience in contract law and data privacy, with biotech/pharma or healthcare industry experience preferred. - Prefer in-house counsel or law firm background with licensing in New York or eligibility for in-house counsel licensure. **Key Responsibilities** - Draft, review, and negotiate a wide range of contractual agreements (e.g., research collaborations, licenses, data use, confidentiality). - Advise internal stakeholders on privacy compliance, including developing and updating privacy provisions in third-party agreements. - Coordinate with cross-functional teams and external partners to resolve privacy-related contractual issues. - Create and maintain privacy contracting tools, playbooks, training materials, and policy updates. - Act as a liaison between Transactions Law and Data Privacy Office, addressing policy alignment and compliance. - Provide rapid, accurate guidance on domestic and international privacy law queries. **Required Skills** - Expertise in data privacy laws (U.S. and global) and intellectual property protections. - Advanced contract drafting, negotiation, and strategic analysis skills. - Strong legal writing, oral communication, and stakeholder partnership capabilities. - Business acumen to balance regulatory compliance with organizational objectives. - Ability to manage multiple high-priority matters under tight deadlines. **Required Education & Certifications** - Juris Doctor (JD) with exceptional academic credentials. - Active license to practice law in New York or eligibility for in-house counsel licensure. - Demonstrated experience in life sciences, data privacy, and transactional legal frameworks.
Cambridge, United states
On site
Senior
11-10-2025
Company background Company brand
Company Name
BioSpace
Job Title
Maintenance Technician III (Afternoon Shift)
Job Description
**Job Title:** Maintenance Technician III **Role Summary:** Perform preventive and corrective maintenance on GMP/non-GMP equipment in a high-tech biomanufacturing environment. **Expectations:** - Operate in sterile, controlled environments with strict compliance to safety and regulatory standards. - Manage shifting priorities, flexible schedules (including evenings, weekends, and extended shifts), and emergency call-ins. **Key Responsibilities:** - Execute routine preventive maintenance and corrective actions on production/facilities equipment (clean-in-place skids, HVAC, boilers, process systems, etc.). - Troubleshoot equipment malfunctions using diagnostic tools; monitor/system failures to maintain operational integrity. - Adhere to SOPs, GMP, EHS guidelines, and local codes during all tasks. - Inspect, test, and document equipment verification and certification. - Coordinate repairs with staff/contractors to minimize downtime. - Maintain clean, safe workspaces and detailed work order logs. **Required Skills:** - GMP environment experience (food, cosmetic, pharmaceutical). - Ability to read mechanical schematics and blueprints. - Organizational, communication, and computer literacy. - Proficiency in multi-tasking under dynamic priorities. **Required Education & Certifications:** None specified (Prefer Industrial Mechanic/Electrician certifications or technologist diploma).
Mississauga, Canada
On site
Junior
12-10-2025
Company background Company brand
Company Name
BioSpace
Job Title
Manager, HCP Engagement Operations Sponsorships & Joint Working
Job Description
**Job Title** Manager, HCP Engagement Operations Sponsorships & Joint Working **Role Summary** Lead the operational management of sponsorships and joint‑working activities with healthcare professionals across international markets. Ensure alignment with company policies, regulatory requirements, and industry standards while driving continuous process improvement and operational excellence. **Expectations** - Oversee full lifecycle of sponsorship requests, approvals, and contract execution. - Manage contract templates, amendments, and legal collaborations for third‑party agreements. - Coordinate vendor performance, SLAs, and critical metrics. - Forecast and supervise budgets; produce finance reporting. - Serve as primary contact for internal stakeholders on all sponsorship and joint‑working matters. - Maintain audit‑ready documentation and support process standardisation. - Analyse program effectiveness, identify optimisation opportunities, and implement best‑practice tools. **Key Responsibilities** - Handle contract management, execution, and compliance. - Update and maintain contract templates and collaborate with legal teams. - Coordinate sponsorship activities with HCPs adhering to local regulations. - Supervise external vendor performance and track SLA compliance. - Forecast budgets, monitor expenditures, and report financial status. - Provide a single point of contact for sponsorship inquiries. - Ensure accurate documentation and audit readiness. - Develop and refine standard processes, templates, and operational tools. - Partner with cross‑functional teams to evaluate program outcomes and identify improvements. **Required Skills** - Proven experience in contract and vendor management in an operational setting. - Budget management, forecasting, and reporting in a regulated environment. - Proficiency with CRM or event management systems and data tracking/analytics. - Strong organisational, detail‑oriented, and proactive problem‑solving skills. - Ability to collaborate across a matrixed, global organisation and manage cross‑cultural partners. - Solid understanding of pharmaceutical sponsorship regulations (EFPIA, ABPI, GDPR). **Required Education & Certifications** - Bachelor’s degree in Business, Life Sciences, or related field. - Minimum of 35 years’ experience in HCP engagement operations, sponsorship management, or commercial/medical affairs support within the pharmaceutical, biotech, or life sciences industry.
London, United kingdom
On site
30-11-2025