Site Management Lead (Boston)
Posted 12 days ago
Job Viewed
Job Description
Direct message the job poster from Beacon Hill
Senior Staffing Consultant II at Beacon Hill Life SciencesPosition Summary:
The Site Management Lead is the regional representative of our Client for coordinating operational aspects of clinical studies, supporting study teams with activities from startup, recruitment, database lock to close out, fulfilling sponsor oversight activities, and maintaining site relations and site staff engagement. They are responsible for development and management of clinical sites being considered and/or participating in clinical trials, including site feasibility, study enrollment in accordance with the enrolment plan, issue management, delivery of database locks, monitoring oversight and inspection readiness at all times for assigned sites, and improving the overall experience of sites and site staff by developing and executing site engagement, communication and support strategies.
Key Responsibilities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out, driving a superior customer experience
- Apply regional expertise to oversee investigator site start-up activities to ensure timelines are met, including site identification and qualification, collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for review of IRB/EC submissions (ensuring country specific requirements are incorporated, where applicable), facilitate negotiation and execution of clinical trial agreements, site training and participate in site initiation visits
- Identify potential opportunities to accelerate clinical trial enrollment and effectively drive timelines aligned with company priorities
- Support delivery of database locks per forecasted timelines and site close out
- Serve as a key member of the Clinical Study Team and oversee site monitoring activities at clinical trial sites as performed by a Contract Research Organization (CRO) or internally for all programs (monitoring oversight), including identification, mitigation and escalation of significant findings and trends at a site and country level
- Conduct onsite and remote monitoring oversight visits to evaluate CRA site monitoring performance; communicate trends and significant findings with the CRO and the trial team(s)
- Responsible for monitoring site and country level metrics to proactively identify risks/issues and propose mitigations
- Generate, utilize, and oversee metrics and tools to ensure the site monitoring activities are conducted in accordance with applicable regulations, SOPs, and trial objectives
- Serve as an effective communication bridge between sites, vendors and trial management team
- Collaborate with cross-functional internal and external study teams to remove barriers to trial execution at a site and/or country level
- Establish and develop strong professional relationships with clinical investigators, study coordinators and other site staff to expand/maintain clinical research partnership opportunities and optimize delivery of clinical trials
- Support identification and development of clinical research nave sites, through training and supporting development of processes to conduct clinical research
- Create institutional knowledge and libraries of country specific requirements for future reference
- Additional local responsibilities as required and appropriate for the local region
- Frequent travel in assigned regions, with up to 50% or higher domestic and/or international travel
Key Skills, Abilities, and Competencies
- Strong understanding and knowledge of regional clinical research landscape, guidelines and regulations
- Strong verbal and written communication skills
- Demonstrated interpersonal skillset necessary to guide and maintain internal and external collaborator relationships
- Challenge the norm with creative solutions
- Ability to work in a fast-paced environment
- Ability to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity
- Foster open and transparent communication
- Demonstrated ability to effectively influence and implement change and continuous improvement
- Collaborate effectively in a dynamic, cross-functional matrix environment
Requirements
Education, Registration &/Or Certifications:
- Bachelors degree or equivalent in Science/Health Care related field; advanced degree preferred but not required
Experience
- 6+ years of experience in a clinical monitoring role (field monitoring experience required) or equivalent.
- 3+ years experience in a lead clinical monitoring or CRA manager role, project/trial management position, or equivalent
- Experience in a monitoring oversight role preferred
- Seniority level Associate
- Employment type Contract
- Job function Project Management
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#J-18808-LjbffrSenior Construction Foreman
Posted 3 days ago
Job Viewed
Job Description
Key Responsibilities:
- Supervise and direct the work of construction crews.
- Ensure all construction activities are performed safely and according to plans.
- Coordinate daily tasks and resource allocation on site.
- Interpret blueprints, schematics, and construction documents.
- Monitor work quality and ensure adherence to specifications.
- Manage on-site material and equipment needs.
- Enforce safety regulations and conduct safety briefings.
- Report on site progress and identify potential issues.
- Train and mentor junior site personnel.
- Collaborate with project managers and superintendents.
- High school diploma or equivalent; Trade school or apprenticeship completion preferred.
- Minimum of 7 years of experience in the construction industry.
- Minimum of 3 years of experience in a supervisory or foreman role.
- Proven knowledge of construction trades, safety regulations, and best practices.
- Ability to read and interpret blueprints and construction drawings.
- Strong leadership, communication, and problem-solving skills.
- Physical ability to work on construction sites and lift heavy materials.
- OSHA 30 certification is highly desirable.
Director - Manufacturing Site Inspection Management, Quality
Posted 7 days ago
Job Viewed
Job Description
General/Position Summary
The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection management. The role is responsible for designing the program, identifying risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution.
Additional responsibilities include support for external site inspection readiness. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with significant experience in establishing manufacturing site inspection programs from development to commercial and successfully executing to maintain a constant inspection readiness site.
This is a Cell & Gene manufacturing site based role located in the Boston Seaport.
Key Duties & Responsibilities
* Serves as manufacturing site CMC Inspection Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site inspection program.
* Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
* Develops and implements strategies for inspection readiness, including mock inspections, training, and site preparation visits.
* Partners with the site QA leadership and cross-functional leadership for coordination and alignment in ensuring overall execution, readiness and site maturity adequacy.
* Collaborating with cross-functional teams to develop and implement effective corrective and preventive actions (CAPAs) in response to audit and inspection findings.
* Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of site for pre-approval inspection and other inspection readiness.
* Monitoring and analyzing key performance indicators (KPIs) related to internal audits, inspections and compliance, and identifying areas for improvement.
* Communicates status, risks, and escalations with management through governance forums and ongoing report outs.
* Leads/Engages/Support in Quality projects ensure successful planning, execution and on-time delivery.
* Ensure activities and deliverables are in compliance with Global HA regulations, Vertex SOPs and industry best practices.
* Provides functional area leadership and management through the execution of Goals, Employee learning and development, and budget forecasting.
Required Education Level
Bachelor's degree in a Scientific/Engineering/Lifesciences field.
Required Experience
Typically requires 12+ years of relevant industry experience in a commercial manufacturing site in biotechnology/regulated pharmaceutical environment.
Required Knowledge/Skills
* In-depth GxP experience with current knowledge of industry trends, HA regulations & expectations, and best practices
* Extensive knowledge of commercial readiness, with inspection planning/coordination and management for regulatory authority inspections at a manufacturing site
* Broad knowledge of Cell & Gene therapy and/or Biologics, aseptic manufacturing processing.
* Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
* Strong leadership skills with the ability to organize and execute tasks effectively.
* Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
* Ability to apply risk management principles to decision making and operational priorities.
* Ability to manage multiple projects, work in a dynamic environment and communicate effectively with senior leaders.
Other Requirements
5% travel may be required.
#LI-onsite
Pay Range:
$176,000 - $264,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
Director - Manufacturing Site Inspection Management, Quality (Boston)
Posted 12 days ago
Job Viewed
Job Description
Job Description
General/Position Summary
The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection management. The role is responsible for designing the program, identifying risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution.
Additional responsibilities include support for external site inspection readiness. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with significant experience in establishing manufacturing site inspection programs from development to commercial and successfully executing to maintain a constant inspection readiness site.
This is a Cell & Gene manufacturing site based role located in the Boston Seaport.
Key Duties & Responsibilities
- Serves as manufacturing site CMC Inspection Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site inspection program.
- Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
- Develops and implements strategies for inspection readiness, including mock inspections, training, and site preparation visits.
- Partners with the site QA leadership and cross-functional leadership for coordination and alignment in ensuring overall execution, readiness and site maturity adequacy.
- Collaborating with cross-functional teams to develop and implement effective corrective and preventive actions (CAPAs) in response to audit and inspection findings.
- Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of site for pre-approval inspection and other inspection readiness.
- Monitoring and analyzing key performance indicators (KPIs) related to internal audits, inspections and compliance, and identifying areas for improvement.
- Communicates status, risks, and escalations with management through governance forums and ongoing report outs.
- Leads/Engages/Support in Quality projects ensure successful planning, execution and on-time delivery.
- Ensure activities and deliverables are in compliance with Global HA regulations, Vertex SOPs and industry best practices.
- Provides functional area leadership and management through the execution of Goals, Employee learning and development, and budget forecasting.
Required Education Level
Bachelor's degree in a Scientific/Engineering/Lifesciences field.
Required Experience
Typically requires 12+ years of relevant industry experience in a commercial manufacturing site in biotechnology/regulated pharmaceutical environment.
Required Knowledge/Skills
- In-depth GxP experience with current knowledge of industry trends, HA regulations & expectations, and best practices
- Extensive knowledge of commercial readiness, with inspection planning/coordination and management for regulatory authority inspections at a manufacturing site
- Broad knowledge of Cell & Gene therapy and/or Biologics, aseptic manufacturing processing.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
- Strong leadership skills with the ability to organize and execute tasks effectively.
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
- Ability to apply risk management principles to decision making and operational priorities.
- Ability to manage multiple projects, work in a dynamic environment and communicate effectively with senior leaders.
Other Requirements
5% travel may be required.
#LI-onsite
Pay Range:
$176,000 - $264,000Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
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