Senior Product Manager (Pharma Clinical Trials) Job at 360 Resourcing Solutions (Oxford)

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites
Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Partner with SCP and the study team to define and support recruitment initiatives at site level

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Senior Clinical Research Associate (Oncology Experience Required)

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Minimum of 5 years' experience in CRO or Pharma trials environments
Experience in oncology trials and RECIST criteria is essential
Fluency in English is required
Proficiency in local language is required
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders

Job Responsibility

Ensuring regulatory, ICH-GCP and protocol compliance
Verifying the process of obtaining informed consent
Assessing factors that might affect subject safety and clinical data integrity
Conducting monitoring activities using different methods (e.g., on site and remote)
Conducting source document review and verification
Managing reporting of protocol deviations
Applying query resolution techniques
Performing Investigational Product (IP) inventory, reconciliation and review
Verifying IP dispensation and administration
Managing reporting of identified issues

Senior Clinical Research Associate (Oncology Experience Required) - UK (Remote) - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in oncology trials and RECIST criteria is essential
Minimum of 4 years' experience in CRO or Pharma trials environments is also essential
Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders
Proficiency in local language is required
Fluency in English is required

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensuring regulatory, ICH-GCP and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
immediately communicates/escalates significant issues to the project team and develops action plans
Verifies the process of obtaining informed consent has been adequately performed and documented
Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity
Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
Conducts source document review and verification of appropriate site source documents and medical records
Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
Manages reporting of protocol deviations and appropriate follow up

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Advanced Technology
Diverse therapeutic areas and project exposure

Fulltime

Senior Manager Supply Planning

Beam is seeking a highly motivated individual to join our Supply Chain team. The...

Location

United States , Cambridge

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS/BA degree in Business, Science, Engineering or related field with 8-10+ years of experience in global supply chain from pharma, biotech or cell & gene therapy companies
Master's degree or MBA preferred
Prior drug development, manufacturing, and clinical operations experience is a plus
Passion for patients, collaborative and effective leader
Knowledge of practical implications of Sarbanes-Oxley controls
Knowledge of continuous improvement methodologies and tools
Strong organizational and facilitation skills, with high degree of customer focus
Expertise and track record in manufacturing and supply chain execution and oversight
Extensive experience in supply chain planning, SAP ERP system, capacity modeling, supply network strategy and optimization
Expertise and have a proven track record in supply chain risk management

Job Responsibility

Production & Capacity Planning: Develop and maintain a rolling 12–24-month master production schedule (MPS) aligned with demand forecasts and manufacturing constraints
External Network Collaboration: Lead planning and partner with key stakeholders to ensure supply continuity across the Contract Manufacturing Organizations (CMOs) and 3PLs
Sales & Operations Planning (S&OP): Drive the monthly S&OP cycle, including rough-cut capacity planning and scenario analysis. Partner cross-functionally to refine demand forecasts and execute supply network analysis to support both tactical and strategic goals
Inventory Optimization: Ensures appropriate inventory levels to minimize excess while preventing stockouts, specifically managing shelf-life/expiry for temperature-sensitive products like Critical Materials (pDNA, mRNA, gRNA, mAb, lipids), Drug Substance, and Bulk/Finished Drug Product
Clinical/Launch Readiness: Orchestrate supply for clinical trials or support new product introductions (NPI) and commercial launches
Risk Management: Proactively identify supply disruptions and develop mitigation strategies or business continuity plans
Process Improvement: Drive Global Supply Chain excellence through project management, process enhancement, and the deployment of digital tools that streamline business execution and strategic decision-making
Metrics: Leverage data-driven KPIs to track performance, ensuring accountability and optimizing the balance between operational efficiency and financial health
Systems: Optimize supply and inventory planning accuracy through utilization of SAP, driving improved stock maintenance and network visibility. Spearhead the design and execution of SAP enhancements, including Integrated Business Planning (IBP) and Jurisdictional Control (JC), to streamline end-to-end supply chain functions
Other duties as assigned

Fulltime

Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician)

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A Master's or Doctoral-level degree in applied statistics, health economics, and related quantitative fields
A minimum of 3 years of hands-on experience working in the pharmaceutical industry, a consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus)
Demonstrate in-depth knowledge of Access and HTA, clinical research and development methods, and international payer evidence requirements
Skilled in research design and statistical methods, such as Generalized Linear Models, Survival analysis, Network Meta-Analysis, and Bayesian statistics and are proficient in R and GitLab (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus)
Strong strategic, collaboration, and communication skills, strong organization, planning, and prioritization skills with an ability to meet tight deadlines, and strong written and verbal communication skills in English

Job Responsibility

Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies
Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans
Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.)
Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models
Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications
Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter
Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts
Ensuring that all assigned projects are being conducted in an efficient manner and that quality and client satisfaction is maximized at all times
Guide the Senior associates and Associates in their daily duties and to flag any areas of acute training needs to their line managers
Maintaining client relationships on their projects

What we offer

Flexible work arrangements (remote work)

New

Vice President

iCapital is looking to hire an investment product specialist Vice President to s...

Location

China , Hong Kong

Salary:

Not provided

iCapital Network

Expiration Date

Until further notice

Requirements

10+ years of experience working within the alternative investment industry in a client facing capacity (e.g., Investor relations at GPs or distribution specialist at placement agents, fund of funds and asset management firms with alternative investment product experience)
A self-starter who demonstrates the ability to work in a fast-paced entrepreneurial environment and follow a rigorous sales process
Strong team orientation with exceptional organizational and interpersonal skills especially in a cross-boarder and small team-working environment
Strong with Microsoft powerpoint and has excellent verbal and written communication skills
Local regulatory licensing is required
Relevant language skills is a plus

Job Responsibility

Leverage a consultative sales process to acquire new relationships, expand existing client relationships, and service assets under management
Develop high level of sales proficiency with iDirect offerings in private equity, private credit, and hedge funds and other future iDirect products and a good understanding of the asset class as well as product comparison purposes
Traveling is required to markets to meet with gatekeepers, advisors, industry bodies, end clients in support of the broader sales and educational effort
Assist in the planning and execution of roadshows and conferences
Work alongside the in region Client Solutions team personnel on client pitches, product positioning, and sales campaigns
Leverage technology input and reporting tools to support sales management activities

Fulltime

Customer Assistant II

Location

United States , Amherst

Salary:

26.06 - 29.33 USD / Hour

Massachusetts Municipal Association

Expiration Date

Until further notice

Requirements

High school degree or equivalent PLUS one to three years of experience in accounting, bookkeeping, or cash handling
OR any equivalent combination of related education and experience that demonstrates the ability to successfully perform the responsibilities of the position

Job Responsibility

Perform a full range of complex procedural accounting and clerical duties associated with computation, reconciliation and posting to accounts for town collection areas (e.g., Water and Sewer, Parking)

Fulltime

Care Assistant - Days

Are you ambitious? Do you want something else? Are you looking for new energy? W...

Location

United Kingdom , Poynton

Salary:

12.75 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

No previous experience or qualifications needed
Enhanced DBS check in relation to Children and Adults required

Job Responsibility

Support with personal care needs
Help residents take part in a wide range of special interests and activities that support their health and wellbeing such as arts and crafts, watching the footie, drama, musical evenings, gardening, shopping trips and social occasions

What we offer

Discounts on Shopping, Fashion, Days out, Travel, Entertainment and lots more
Flex Earn – Earned wage access
FREE face-to-face counselling for you and your family
Staff recognition award ceremonies
£30 voucher available every month for the nominated Employee of the month
Opportunities for training and career progression
Salary Sacrifice Pension scheme
Blue Light Card – up to 50% discount across 100’s of retailers
Access to a FREE eye test and discounted glasses
Cashback card – save up to £500 annually

Fulltime

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Senior Product Manager (Pharma Clinical Trials)

Job Description

Job Responsibility

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