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Flynn Life Sciences Group Inc

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United States
Framingham, MA
Flynn Life Sciences Group Inc

Flynn Life Sciences Group is an executive recruiter and job placement agency focused on the life sciences industry. What makes us different? We're small.

Our Approach is Personal

Flynn Life Sciences Group is an executive recruiter and job placement agency focused on the life sciences industry. For more than fifteen years we have placed the foremost clinical trials, scientific, and bioinformatics candidates into Biotech, Pharmaceutical, Medical Device, and Clinical Research Groups for retained, contingent and contract positions. We will work with

you to find the best candidates for retained search, permanent placement, and contract positions. Our approach is personal -we communicate regularly with all clients, no matter the size of scope of your needs. You can always get Mark or a colleague on the phone. Not only do we provide personalized service, we also know what we're doing. We have multiple years of experience recruiting and placing candidates into positions in the life sciences field. Our philosophy is to find companies the best candidate and employees/contractors the best company without wasting anyone's time. We believe in straight talk. Maybe you're an employer seeking a single addition to your team or a group of contractors for a large project, or maybe you're a candidate looking for a new position? We will listen to you and pay attention to your needs. Then we will go out and find the perfect fit.

07/01/2024

New Monday - New Role
Clinical Trial Manager / Senior Clinical Trial Manager

- Leads the multidisciplinary study ex*****on team and collaborates with other functions as required for implementation and ex*****on of the study(s)
- Serves as the primary Clinical Operations point of contact for cross functional team members and CROs, as appropriate.
- Devises efficient, effective clinical trial ex*****on strategies; guides planning and ex*****on of clinical studies, including management of study budgets / timelines and external vendor(s) management.
- Prepares and/or reviews/approves study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and manuals, CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate.
- Prepares metrics and updates for Leadership, as appropriate. - Proactively identifies, negotiates, and successfully engages the study team in the resolution and/or mitigation of clinical study risks, issues, and challenges and escalates to leadership when appropriate.
- Participates in CRO/vendor Request For Proposal (RFP) and selection process for outsourced activities Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File) May serve as a line manager to one or more Clinical Trial Managers (CTMs) and/or Clinical Trial Assistants (CTAs)

Qualifications:
- BS or BA in a relevant scientific or health related field
- A minimum of 5 years of related work experience in the pharmaceutical or biotechnology industry, with at least 3 years in a study management role.
- Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
- Experience in managing CROs and external vendors
- Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project a plus Some travel may be expected for this position including internal meetings, conferences or training events

For immediate consideration please send your updated CV to [email protected]

06/05/2024

Hot New Position
Sr. Clinical Trial Leader

Sr. CTL:
- Manages projects/work streams with high complexity, risk, impact, and reach.
- Manages large-sized global clinical teams with members also from outside the direct working environment.
- Coordinates stakeholders from closely related areas and beyond. - Demonstrates skills in successfully leading international teams in the matrix organization and directs, influences, and motivates people; creates and leads a positive working climate.
- Develop and lead operational and therapeutic area training for internal and external study team members.
- Directs multiple studies in parallel and/or be called upon for program management duties.
- Exhibits Subject Matter Expert level understanding of multiple functions and functional processes.
- Accountable for successful project ex*****on including definition of milestones and clarification of project scope. Receives minimal guidance and works independently.
- Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical expert on cross functional teams or projects

JOB SPECIFICATIONS:
- Advanced degree desirable; PM certification desirable
- Ideally 10 years clinical research experience with at least 5 years of direct trial management experience
- Some experience in oncology preferred.
- Experience in CRO oversight is required
- Manages large sized global clinical trial team
- Works with minimal or no supervision
- Ability to mentor junior staff Self-directed and proactive handles multiple complex tasks Strong organization, documentation, and communication skills.
- Excellent interpersonal skills: ability to collaborate across disciplines.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
- Ability to travel up to approximately 30% of time. Hybrid on-site in Boston two days per week.

For more information or to submit your CV for review, contact [email protected]

06/04/2024

New Day - New Position
Client seeking CTA/ Sr. CTA

Responsibilities include:
- Responsible for day-to-day operational management of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements
- Supports the multidisciplinary clinical study team and collaborates with other functions as required for implementation and ex*****on of the study(s)
- Contributes to the development of study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and tools, CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate.
- Contributes to study dashboards and metrics reports, as appropriate.

Qualifications:
- Requires a relevant scientific or health related field
- Bachelor’s degree with at least 2 years of relevant work experience in a pharmaceutical or biotechnology or CRO environment
- Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
- Experience in managing CROs and external vendors

Click the link for the full job description or send your CV to [email protected] for immediate consideration

05/14/2024

Another new day, another new position
Client seeking - Clinical Data Manager

- Act as a liaison with CROs, third party data vendors, and EDC vendors
- Oversees clinical database design and production, ensuring that CROs, vendors, and internal staff meet the highest quality standards, ensuring completeness, correctness, and consistency of clinical data and outputs
- Oversees the creation and approval of Data Management study documentation including, but not limited to, eCRFs, clinical database specifications, CCGs, DMPs, data handling guidelines, data review plans, data transfer specifications/agreements, external vendor data reconciliation plans, and SAE reconciliation plans
- Reviews clinical data listings and reports on performance and quality; review clinical data within studies and across programs for trend analysis Understands all aspects of the study protocols and statistical analysis plans as they relate to data management deliverables and serve as a knowledgeable point person on study teams for data management activities
- Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed and communicates project status, metrics, risks, and issues
- Assist as needed with clinical documents such as clinical protocols, investigator brochure updates, annual reports, and status updates

Qualifications:
- Bachelor’s degree, or equivalent, in a biomedical, life science, or related field of study
- Minimum of 3 years of relevant clinical data management experience within the Pharma, Biotech, or CRO industry Oncology or immunology/inflammation experience required
- Experience with CRO vendor oversight is preferred
- Familiarity with advanced Excel functions, SAS, and SQL is a plus
- Strong organizational skills along with a creative, proactive, problem-solving, and flexible attitude Strong written and verbal communication skills
- Ability to collaborate effectively with the cross-functional study team and external partners
- Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC) (Oracle Inform and Medidata Rave), clinical data management systems, and industry wide coding dictionaries (MedDRA and WHODrug)

For immediate consideration contact [email protected]

05/13/2024

New Monday - New Biostatistician Role

- Develop statistical sections of protocols and statistical analysis plans and assist in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses from regulatory agencies
- Make recommendations on appropriate study design, methodology, analytic and operational approach, sample size and power considerations
- Ensure that clinical trials meet statistical requirements (ICH, FDA, EMA guidelines) and are conducted with appropriate rigor
- Provide ongoing reporting of clinical trial data as needed
- Perform exploratory data analyses on patient subgroups
- Collaborate with translational science and pharmacokinetic colleagues as needed to analyze early phase trial data

Qualifications:
- Ph.D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 6+ years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 8+ years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience).
- Ability to analyze, interpret, and summarize clinical and scientific data using a range of advanced statistical techniques for statistical analyses
- Skill in preparing graphical data displays Knowledge of scientific approach and methodologies as well as principles, concepts, methods, and standards of statistical research

Qualified interested candidates should contact [email protected] for immediate consideration

04/23/2024

New Tuesday - New Position

Client seeking Sr. Clinical Trial Manager - Fully Remote

Key responsibilities:
- Manage or assist in managing study ex*****on, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial.
- Contribute/establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Proactively identify risks, offer mitigation strategies and support implementation Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
- May oversee investigator recruitment/ selection across project Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.
- Participate in ad hoc clinical operations’ initiatives and programs. Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.

Other responsibilities:
- Participates in meetings with investigator sites, key opinion leaders and consultants as needed.
- Facilitate the development of clinical trial agreements and other relevant documents.
- Contribute to request, creation and review of scope of work and budgets; participate in vendor performance management and issue resolution.
- Review and provide input for site budgets, manage clinical trial budget, providing ongoing financial reporting and projections to finance.

For more details or to submit your CV for review, contact [email protected]

04/22/2024

New Monday - New Position

Client seeking - CTM
Job responsibilities include, but are not limited to:
Responsibilities:
- Primary operational contact for ex*****on of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Lead weekly meeting of the Clinical Trial Team on status of assigned studies.
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate Operational input into study documents such as synopsis, protocol, Informed Consent Forms, CRFs, CRF Completion Guidelines, Study Ex*****on Plans, Clinical Data Review Plan, etc.
- Development/coordination of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.

Qualifications:
- Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
- Minimum of 3 years of progressively increasing Clinical Operations experience within the Pharma, Biotech or CRO industry; Oncology/Immuno-oncology or immunology/inflammation experience required
- Good understanding of US regulatory and compliance requirements for clinical research
- Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to confidential information and strategies Can communicate effectively

For more details or to submit your CV for review please contact [email protected]

04/02/2024

NEW GCP- QA Consultant Position Open

The position will instill concepts of quality management, continuous improvement, and inspection readiness so that Clinical Research programs can consistently withstand inspections by internal QA or external regulatory authorities globally.
RESPONSIBILITIES:
- Analyze and track all audit reports globally (internal QA or Regulatory Authority audits) to insure that responses and corrective actions applicable to Clinical Operations are completed and audits are closed in a timely manner.
- Generate, coordinate, and track Corrective and Preventative Action Plans (CAPA) within Clinical Operations.
- Determine the need for new processes or revisions to processes (e.g. SOPs, Work Instructions).
- Determine the need for training programs or revisions to training curricula.
- Act as the primary contact and resource for Clinical Operations during regulatory inspections by competent authorities.
- Support project teams and coordinate resources in planning and responding during inspections.
- Track and ensure that all staff in Clinical Operations is current with training requirements.
- Assist in the review and development or revision of processes and best practices (SOPs)

Qualifications
· Extensive experience in conducting and managing Quality Assurance Audits (GCP) and Corrective Action Plans (CAPA) - 6 or more years experience
· A thorough understanding of the design, implementation and management of clinical trials; experience in monitoring and managing clinical research studies is preferred
· In depth knowledge of Good Clinical Practices (ICH) with experience in global application; knowledge of quality standards across a range of geographic regions (countries)
· Experience in developing Standard Operation Procedures and operating in a Quality Management System.
· Experience in establishing inspection readiness focus and process

Qualified candidates should contact [email protected] for immediate

03/26/2024

Client with NEW Clinical Trial Manager position

- Provides Clinical Operations expertise and leadership in the management of Contract Research Organizations (CROs) and other specialized vendors to ensure successful clinical trial implementation and ex*****on.
- Provides operational management and oversight for the successful management of clinical trials through internal clinical trial teams and through the use of CROs and internal resources.
- Conducts project risk analysis and develops risk mitigation strategies for a variety of complex problems in order to maintain study deliverables.
- Plays a role in ensuring that the Trial Team effectively interfaces with key functional groups.
- Contributes to the development and presentation of clinical trial operational updates to senior/executive leadership.
- Oversees, manages and ensures clinical trials are executed according to key performance indicators (timelines, budget, operational and quality standards).
- Maintains procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems.

Qualifications:
- Bachelor’s degree preferred in a relevant scientific or healthcare discipline or equivalent experience
- Must have phase III experience
- Minimum of 5 – 10+ years of Clinical Operations experience in Biopharmaceutical development with experience moving product candidates from Phase I through pivotal studies or equivalent, title is considered based on all qualifications and number of years of experience.
Qualified interested candidates should contact [email protected] for immediate consideration

03/11/2024

New Monday - New Clinical Trial Manager Position

- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Operational input into study documents such as synopsis, protocol, Informed Consent, CRFs, CRF Completion Guidelines, Study Ex*****on Plans, Clinical Data Review Plan, etc.
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight Development/coordination of study training and materials for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
- Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) held by the CRO

Qualifications:
- Bachelor’s degree, or equivalent, preferably in a biomedical, life science or related field of study
- Minimum of 5 years of progressively increasing clinical trial management experience within the Pharma, Biotech or CRO; Oncology/Immuno-oncology experience required
- Good understanding of global regulatory and compliance requirements for clinical research
- Solid teamwork, organizational, interpersonal, and problem solving skills Critical thinking skills for problem solving and have the strategic thinking capacity to drive the study(ies) and understands the implications of decisions that affect study outcomes, budgets and timelines.
- Can effectively communicate both verbally and in written form Ability to influence and collaborate well with colleagues and partners in a fast-paced environment

Qualified interested candidates should contact [email protected] for more details or to submit your CV for review.

03/05/2024

Another new position today

Client seeking: Sr. Manager, Clinical Drug Supply

This position will design, develop, and implement the clinical supplies strategy to ensure appropriate continuous supply of material. They will work closely with CMC/manufacturing, Clinical Operations, Quality Assurance, Regulatory Affairs, Program Management and third-party CMO vendors. Strong cross-functional team leadership and project management skills are essential requirements of the role.
· Experience overseeing drug management for multiple concurrent clinical trials from first-in-human studies through to pivotal studies, requiring in-depth understanding of GMPs, project management, IRT, drug accountability and supply forecasting.
· Drive the clinical label text creation, translation, approval process and printing activities for global clinical trials.
· Experience managing and working with Contract Packaging Vendor for scheduling and delivery of secondary packaging, labeling, QP services, IRT integration, distribution and return drug management activities at global depots.
· Working with vendors and/or CROs to contribute to the development within the IRT system requirements, user acceptance testing, and drug supply management.
· Responsible for Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management.

Here’s What You’ll Bring to the Table:
· BA/BS degree, 5 + years of relevant experience in clinical supply chain management in the biopharmaceutical industry associated with complex global trials.
· Anticipates and proactively identifies, recommend creative solutions or escalate issues for project resolution. · Ability to effectively prioritize and manage multiple projects and tasks.
· A flexible approach to problem solving and strong negotiations skills.
· Excellent oral and written communication skills required with the ability to effectively understand and present information and deal confidently with internal and external stakeholders.
· Initiative, excellent attention to detail, with excellent problem-solving ability and highly developed organizational and time- management skills are required.

Qualified interested candidates should contact Mark Flynn at Mark@FlynnLSG

03/05/2024

New Day, New Opportunity

Client seeking: Senior Statistician

Responsibilities Data Analysis:
- Routinely directs and supervises data analytic activities of more junior statisticians and/or leads complex projects.

Study Design:
- Trains, mentors and oversees the design activities of more junior statistical staff. Acts as a key participant in the articulation of the collaborative vision, working with program leaders and clinical research directors on scientific program direction and research portfolio.

Qualifications:
- Master’s degree in Statistics or Biostatistics.
- Ten years of experience required.
- Knowledge of UNIX/Linux and statistical software such as R or SAS.
- Expert at statistical methodology, and the use of statistical software, coding, data analysis and effective presentation of results.
- Comfortable with the statistical literature and able to implement state-of-the-art analytic techniques.
- Able to construct and implement complex study designs. Understands the nuances of data wrangling and ability to use sound principles of reproducible research methods.
- Adept at performing complex analysis methods and assess underlying assumptions.

For more details or to submit your CV for review, please contact Ray Barrieault at [email protected]

Address

30 Speen Street Suite 100
Framingham, MA
01701

Opening Hours

Monday	7am - 5pm
Tuesday	7am - 5pm
Wednesday	7am - 5pm
Thursday	7am - 5:30pm
Friday	9am - 5pm

Website

http://www.flynnlsg.com/

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