Search Results: 192 vacancies
...of impurity ELISAs.
Have strong understanding of ICH guidelines regarding host cell proteins(HCPs).
Support and manage external CRO studies by reviewing validation and qualification data, methods, and reports.
Independently analyze, compile, and present data in...
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Holiday work
Full time
Contract work
Monday to Friday
...required
Experience in basic molecular biology techniques required
Experience working in a team environment required, industry (CRO, pharmaceutical, biotech) experience is preferred
Fluency in spoken and written English is a prerequisite for the role Role...
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Weekend work
Day shift
Afternoon shift
Monday to Friday
...to ensure compliance with required regulatory and ICH GCP quality standards and consistency with SOPs.
* You will partner with the CRO to lead, plan, and execute clinical Investigator meetings study meetings, as needed.
* You and your team will participate in preparation...
Suggested
...chemistry, biochemistry, or related discipline
~3+ years of experience, preference given to candidates with previous laboratory and/or CRO experience.
~ Must have a thorough understanding of PK data and functional knowledge of routine preclinical PK-supporting...
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Contract work
...including the essential Trial Master File (TMF).
Requirements
About you:
At least 7 years of experience in the biopharma or CRO industry is required
Preferably some experience in managing clinical sites
Demonstrated excellence in managing clinical...
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...Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing
Oversees and works directly with CROs, vendors,...
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Flexible hours
3 days per week
...or relevant Healthcare discipline and 3+ years related experience in conduct and monitoring of clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry)
+ A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards...
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...enrollment, clinical monitoring, GCP and protocol compliance, from the clinical sites, CROs and vendors.
You will coordinate with the CRO and the Relay Tx Clinical Operations Lead to support planning from study initiation through study closure.
You will maintain study...
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...as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites
Act as company liaison with CMO/CTL/CRO to coordinate in method development and method transfer across various CMO/CTL/CRO sites as needed
Conduct review of laboratory data...
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Work experience placement
...and GLP experience a plus.
Demonstrated knowledge and understanding of quality compliance principles with specific focus on GMPs (CRO compliance knowledge a plus).
Additional Experience Desired:
Biological Drug Substance production
Production of...
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...monitoring clinical study progress and surveillance of key efficacy and safety data points
* Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation
* Provide input in internal/external...
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For contractors
Local area
Night shift
...experience)
Position Summary
Kelly Science & Clinical is seeing an Associate Director of Quality to join a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries in Burlington, MA . From early development support...
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Full time
Worldwide
Flexible hours
Day shift
...planning and interaction/negotiation with business partners, due diligence, licensing.
+ Leverage Contract Research Organizations (CRO's) in multiple disciplines to deliver quality return on investment.
+ Develop and manage world-wide supplier relationship, sourcing...
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...unblinded site visit reports
Ensure Unblinded study team processes are in place and training is developed and delivered, working with CRO, contractors, and internal staff.
Provide a single point of contact for routine support of unblinded CRAs, unblinded site staff,...
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...activities, data collection and reporting, and providing support as needed to the team of field champions.
* Provide input to both the CRO and internal clinical development plans for the study, and ensure study team adherence to the plans.
* Develop and manage study...
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...oversight of Contract Research Organizations (CROs) and other external vendors. Builds solid relationships with key counterparts at CRO(s) and other external vendors
•Coordinates the development and distribution of critical study documents, including Informed Consent...
Holiday work
Contract work
Temporary work
Interim role
Flexible hours
1 day per week
..."
Nice to Have
•Familiarity with Golden Gate or Gibson assembly
Interview Process:
•Multiple Panel interviews with camera on.
Position Comments visible to Supplier: Previous experience in a CRO role, preferred.
No wiggle room in the BR
...With a demonstrated track record in the oversight of all clinical study operational aspects including: budgets, timelines, resources, CRO/vendor selection and oversight of clinical team staff during study start-up, routine monitoring and closeout activities, they will...
Local area
Flexible hours
1 day per week
...and helps support the Enterprise Risk senior leadership team and department wide activities. This role enables the Chief Risk Officer (CRO) to focus on company and department initiatives by proactive engagement and management of business responsibilities ensuring maximum...
Full time
Local area
Work from home
...software.
Interpret results, write up reports, and present data within the organization and at conferences.
Responsible for CRO management for activities aligned with the Imaging work.
Maintain records including electronic lab notebook.
Requirements...
Contract work
Flexible hours
