Global Study Manager II Job at Parexel

Global Study Manager II

Parexel is actively recruiting for an experienced Global Study Manager to join u...

Location

Poland

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies

Job Responsibility

Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
Steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

Fulltime

Global Study Manager

Global Study Manager – This position is a fully client-embedded role, dedicated ...

Location

Poland

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

Bachelor’s degree: life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
Must have proven experience from study feasibility to CSR
Must have at least Ph II and PIII experience – PI & PIV is an asset
Must have cross-functional leadership proven experience, able to drive internal and external meeting
Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
Strong experience in clinical budget management
Strong experience with vendor management including CRO

Job Responsibility

Accountable for delivering the clinical operation activities of the study until study archiving
Generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality
Accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overall study deliverables
Accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendors Oversight Plan, Investigator/CRA Meeting Set Up & associated training, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Safety Management plan, eTMF & vendor set -up
Proactively and effectively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Responsible for operational input into protocol and informed consent form development, and other key study documents
Leads and conducts investigator meetings and other study related meetings

Fulltime

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

Customer Success Manager II

Customer Success Manager (CSM) is a key value to Customer is as a management par...

Location

United States of America , Durham

Salary:

71700.00 - 145300.00 USD / Year

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

5+ years recent experience with Customer Success with high touch engagements
A professional degree or equivalent experience and 7+ years related experience
Basic knowledge of one or more of the following technologies: Wireless, Networking, Cloud, Customer Success tools
Intermediate level skills with Microsoft Office applications
Demonstrated English verbal, written, and typing skills
Demonstrated ability to understand and communicate effectively with a customer at a low technical level and high management level
Team player and mentor
Account management skills are preferred
Demonstrated Program Management skills and high organizational skills required, PMP certification desired
ITIL/ITSM certification desired

Job Responsibility

Customer Success Manager (CSM) is a key value to Customer is as a management partner with the Customer and an integral part and extension of the Customer's IT management structure
Partners with the Customer to utilize industry best practices (ITIL/ITSM) to ensure that the team works with the Customer's IT service management team to help ensure that all other members of the Aruba/HPE service delivery team are fully knowledgeable about the Customer's critical IT services and business objectives
Promotes customer satisfaction within team, prevents customer dissatisfaction issues from occurring, and follows up on any satisfaction issues that arise
Builds positive working relationships with all members of the ARUBA/HPE team
Leverages experience and knowledge through information sharing
Responsible for the overall delivery of the Service to all assigned accounts
The CSM is the Customer's single IT management focal point for all service-related issues, technical escalations, and is the customer's remote service advocate within ARUBA/HPE
Effective at establishing overall goals, developing outcome focused CSP (Customer Success Plans), and action plans to achieve results, has a keen sense of what, when and how to communicate information to management and peers and the actions taken and possible solutions
Provides direction and leadership to the support team and peers based upon organization vision and strategic direction
Strives to make continuous improvements to key processes, seeks to meet business objectives while contributing to the overall success of the department/organization

What we offer

Health & Wellbeing
Personal & Professional Development
Unconditional Inclusion
The expected salary/wage range for this position is provided below
Variable incentives may also be offered

Fulltime

New

Global Site Start Up II - Spain/Poland/Serbia/Romania - FSP

If you want to be part of a leading CRO and transform scientific discoveries int...

Location

Spain

Salary:

220000.00 - 250000.00 PLN / Year

Parexel

Expiration Date

Until further notice

Requirements

Bachelor degree
Minimum 4 - 6 years global SSU management and regulatory submission experience, regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation
Project Management and Clinical Trial Management experience is a must
Demonstrated interpersonal & leadership skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective communication skills via verbal, written and presentation abilities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate across key stakeholders
Ability to build productive study teams collaborations

Job Responsibility

Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making
Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness
Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans
Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc
Ensure timely country submission deliverables (ensure task completion
all roles clarity, identification of critical path items, effective communication pathway)

What we offer

Premium salary
Attractive benefits
Medical care plan: Health, Dental & Vision
Life Assurance
Excellent work environment
Culture of teamwork and collaboration
People who motivate and face challenges together
Innovative technology
Excellent training
Annual performance-based bonus plan

Fulltime

Global Site Start Up II

In this role you will be is accountable for the global execution of site activat...

Location

Serbia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor degree
Minimum 4 - 6 years regulatory submission experience, regulatory document management in Pharmaceutical /CRO industry
understanding of clinical study start up requirements and working knowledge of relevant documentation
Project Management and Clinical Trial Management experience is a must
Demonstrated interpersonal & leadership skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective communication skills via verbal, written and presentation abilities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate across key stakeholders

Job Responsibility

Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making
Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness
Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans
Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc
Ensure timely country submission deliverables (ensure task completion
all roles clarity, identification of critical path items, effective communication pathway)

Fulltime

New

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
Trains and mentors new auditors and manages the guest auditor program
Supports management of external inspections. Tracks and reports the status of external commitments through closure
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

New

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession

Job Responsibility

Researches and determines requirements for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide internal advice
Supervises data input activities and provides impact analysis
Identifies the need for new regulatory procedures and SOPs
Identifies requirements for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the impact of new guidance and regulations
Provides regulatory input and technical guidance on global regulatory requirements
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities

What we offer

Permanent employment contract in a future-proof company bound by collective agreements
Attractive remuneration and comprehensive social benefits
Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts
Exciting and varied working environment

Fulltime

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Global Study Manager II

Job Description

Job Responsibility

Requirements

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