Specialized Tax Services - Research & Development - Senior Associate

New
53208 Milwaukee, Wisconsin PwC

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Job Description

**Specialty/Competency:** General Tax Consulting
**Industry/Sector:** Not Applicable
**Time Type:** Full time
**Travel Requirements:** Up to 20%
A career in our Specialised Tax Services practice, within Corporate Tax services, will provide you with the opportunity to help our clients meet their tax obligations while managing the impact tax has on their business. You'll advise clients on their local and overseas tax affairs, while acting as a strategic consultant related to business analysis, managing working capital, and profit sharing for partners. You'll also help organisations understand the pricing implications of goods and services between related parties, as well as providing advice on tax implications of deals.
Our team helps our clients achieve year to year consistency that leaves them in full compliance and with optimal cash savings. You'll help our clients identify qualifying cash tax savings and refund opportunities as well as gauging the impact of deductions and credits on the effective tax rate.
To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be a purpose-led and values-driven leader at every level. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future.
As a Senior Associate, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to:
+ Use feedback and reflection to develop self awareness, personal strengths and address development areas.
+ Delegate to others to provide stretch opportunities, coaching them to deliver results.
+ Demonstrate critical thinking and the ability to bring order to unstructured problems.
+ Use a broad range of tools and techniques to extract insights from current industry or sector trends.
+ Review your work and that of others for quality, accuracy and relevance.
+ Know how and when to use tools available for a given situation and can explain the reasons for this choice.
+ Seek and embrace opportunities which give exposure to different situations, environments and perspectives.
+ Use straightforward communication, in a structured way, when influencing and connecting with others.
+ Able to read situations and modify behavior to build quality relationships.
+ Uphold the firm's code of ethics and business conduct.
The Opportunity
As part of the Research & Development team you are expected to lead the way as technology-enabled tax advisors who provide advantages through digitization, automation, and increased efficiencies. As a Senior Associate you are expected to analyze complex problems, mentor others, and maintain rigorous standards. You are expected to focus on building client relationships, developing a deeper understanding of the business context, and navigating increasingly complex situations to grow your personal brand and technical knowledge.
Responsibilities
- Lead technology-enabled tax advisory services
- Drive digitization, automation, and efficiency improvements
- Analyze complex tax issues and provide solutions
- Mentor and develop junior team members
- Maintain exceptional standards in every tax deliverable
- Build and strengthen client relationships
- Develop a thorough understanding of the business context
- Inspire and manage team members to deliver quality work
What You Must Have
- Bachelor's Degree
- 2 years of experience
- Commitment to obtain one of the following certifications: CPA, Member of State Bar, Enrolled Agent, Master's - Engineering, Professional Engineer or other professional certifications approved for the practice before being promoted to Manager
- Other business related fields may be considered (such as, Business Administration/Management, Economics, Finance, International Business, Management, Quantitative Finance, Engineering)
What Sets You Apart
- Working knowledge of the tax issues associated with Research and Development
- Skilled technical abilities with research credit regulations from the IRS, research credit case law, and utilizing R&D databases
- Participating in client discussions and meetings actively
- Communicating a broad range of Firm services
- Managing engagements including preparing concise, accurate documents
- Creating a positive environment by monitoring workloads of the team
- Providing candid, meaningful feedback in a timely manner
- Researching business and industry trends to develop a point of view
- Innovating through new and existing technologies, experimenting with digitization solutions
- Working with large, complex data sets to build models and leverage data visualization tools
- Reviewing contracts and finding opportunities to introduce new pricing options
- Other business related fields may be considered (such as, Business Administration/Management, Economics, Finance, International Business, Management, Quantitative Finance, Engineering)
Learn more about how we work: does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. 
For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all.
Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: salary range for this position is: $77,000 - $214,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link:
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Specialized Tax Services - Research & Development Tax - Manager

53208 Milwaukee, Wisconsin PwC

Posted 15 days ago

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Job Description

**Specialty/Competency:** General Tax Consulting
**Industry/Sector:** Not Applicable
**Time Type:** Full time
**Travel Requirements:** Up to 20%
At PwC, our people in tax services focus on providing advice and guidance to clients on tax planning, compliance, and strategy. These individuals help businesses navigate complex tax regulations and optimise their tax positions.
In specialised tax services at PwC, you will focus on providing tax advice and solutions to clients in complex and niche areas of taxation. This includes areas such as accounting methods, fixed-assets and research and development tax credits.
Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same.
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to:
+ Analyse and identify the linkages and interactions between the component parts of an entire system.
+ Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion.
+ Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables.
+ Develop skills outside your comfort zone, and encourage others to do the same.
+ Effectively mentor others.
+ Use the review of work as an opportunity to deepen the expertise of team members.
+ Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate.
+ Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements.
The Opportunity
As part of the Corporate Tax - Specialised Tax Services team you provide exceptional technical knowledge and specialization and industry insights. As a Manager you lead teams and manage client accounts, focusing on strategic planning and mentoring junior staff. You are accountable for project success and maintaining elevated standards. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and principles in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. This role involves working closely on clients with the latest technologies and platforms in lending, digital banking, payments, crypto and blockchain, insurance and real estate.
Responsibilities
- Lead teams and manage client accounts
- Focus on strategic planning and mentoring junior staff
- Oversee project success and maintain elevated standards
- Motivate, develop, and inspire team members
- Leverage team strengths to meet client expectations
- Identify opportunities that contribute to the firm's success
- Embrace technology and innovation in service delivery
- Foster a culture of integrity and authenticity
What You Must Have
- Bachelor's Degree
- 4 years of experience
- CPA, Member of the Bar or other tax, technology, or finance-specific credentials may qualify for this opportunity
What Sets You Apart
- Knowledge of R&D tax issues
- Skills in analyzing organizations for R&D tax benefits
- Technical skills with research credit regulations
- Experience with R&D databases
- Proficiency in client relationship management
- Proficiency in project workflow and budgeting
- Leadership in coaching and providing feedback
- Automation and digitization proficiency
- Knowledge of pricing strategies
Learn more about how we work: does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. 
For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all.
Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: salary range for this position is: $99,000 - $266,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link:
View Now

Specialized Tax Services - Research & Development Tax Senior Manager

53208 Milwaukee, Wisconsin PwC

Posted 3 days ago

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Job Description

**Specialty/Competency:** General Tax Consulting
**Industry/Sector:** Not Applicable
**Time Type:** Full time
**Travel Requirements:** Up to 20%
At PwC, our people in tax services focus on providing advice and guidance to clients on tax planning, compliance, and strategy. These individuals help businesses navigate complex tax regulations and optimise their tax positions.
In specialised tax services at PwC, you will focus on providing tax advice and solutions to clients in complex and niche areas of taxation. This includes areas such as accounting methods, fixed-assets and research and development tax credits.
Growing as a strategic advisor, you leverage your influence, expertise, and network to deliver quality results. You motivate and coach others, coming together to solve complex problems. As you increase in autonomy, you apply sound judgment, recognising when to take action and when to escalate. You are expected to solve through complexity, ask thoughtful questions, and clearly communicate how things fit together. Your ability to develop and sustain high performing, diverse, and inclusive teams, and your commitment to excellence, contributes to the success of our Firm.
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to:
+ Craft and convey clear, impactful and engaging messages that tell a holistic story.
+ Apply systems thinking to identify underlying problems and/or opportunities.
+ Validate outcomes with clients, share alternative perspectives, and act on client feedback.
+ Direct the team through complexity, demonstrating composure through ambiguous, challenging and uncertain situations.
+ Deepen and evolve your expertise with a focus on staying relevant.
+ Initiate open and honest coaching conversations at all levels.
+ Make difficult decisions and take action to resolve issues hindering team effectiveness.
+ Model and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements.
The Opportunity
As part of the Corporate Tax - Specialized Tax Services team you are expected to lead the way as technology-enabled tax advisors who provide benefits through digitization, automation, and increased efficiencies. As a Senior Manager you are expected to lead large projects, innovate processes, and maintain operational excellence while interacting with clients at a senior level to drive project success. You are expected to leverage your specialized knowledge and technical acumen of industry-leading business trends, the firm's client service offerings, and professional industry networks to deliver quality results to clients and provide strategic input into the firm's business strategies.
Responsibilities
- Oversee large-scale projects and confirm timely delivery
- Create and implement innovative processes to boost efficiency
- Maintain exceptional operational standards
- Interact with clients at a senior level to drive project success
- Establish trust with multi-level teams and stakeholders through clear communication
- Encourage and mentor teams to tackle complex issues
- Apply specialized technical knowledge and industry insights
- Deliver results by leveraging the firm's broad service offerings
What You Must Have
- Bachelor's Degree
- 5 years of experience
- CPA, Member of the Bar or other tax, technology, or finance-specific credentials may qualify for this opportunity
What Sets You Apart
- In-depth knowledge of R&D tax issues
- Interviewing clients to recognize tax liability savings
- Technical skills with research credit regulations
- Building and utilizing networks of client relationships
- Managing resource requirements and project workflow
- Supervising teams to create an atmosphere of trust
- Developing new relationships and selling new services
- Familiarity with a CRM system
- Leading as a business advisor
Learn more about how we work: does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. 
For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all.
Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: salary range for this position is: $124,000 - $335,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link:
View Now

Lead Clinical Research Associate

53202 West Milwaukee, Wisconsin $105000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a prominent pharmaceutical company, is seeking an experienced and dedicated Lead Clinical Research Associate (CRA) to oversee clinical trial operations in **Milwaukee, Wisconsin, US**. This hybrid role offers a blend of on-site collaboration and remote flexibility, focusing on ensuring the quality, integrity, and timely execution of clinical studies. The Lead CRA will play a crucial role in managing study sites, monitoring data accuracy, and ensuring compliance with regulatory requirements and protocols. The ideal candidate will possess strong leadership capabilities, a comprehensive understanding of GCP and regulatory guidelines, and a proven ability to manage complex clinical trials.

Responsibilities:
  • Lead and mentor a team of Clinical Research Associates, providing guidance and support throughout study execution.
  • Oversee the initiation, monitoring, and closure of clinical trial sites, ensuring compliance with protocols, GCP, and regulatory requirements.
  • Conduct on-site and remote monitoring visits to assess patient safety, data integrity, and protocol adherence.
  • Ensure accurate and timely source data verification and query resolution.
  • Develop and manage study-related documentation, including Investigator Site Files (ISFs) and Trial Master Files (TMFs).
  • Liaise effectively with investigators, site staff, internal teams, and regulatory authorities.
  • Identify and resolve site-specific issues and deviations promptly, implementing corrective and preventative actions (CAPAs).
  • Contribute to the development and review of study protocols, informed consent forms, and other essential study documents.
  • Manage study budgets and resource allocation for assigned sites or studies.
  • Prepare and present study progress reports to management and stakeholders.
  • Ensure the ethical conduct of clinical trials and the protection of participant rights and welfare.
  • Stay updated on relevant regulations and industry best practices.
  • Participate in audits and inspections as needed.
  • Train site personnel on study procedures and regulatory requirements.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related field; Master's degree preferred.
  • Minimum of 7 years of experience as a Clinical Research Associate, with at least 2 years in a Lead or Senior CRA capacity.
  • Extensive knowledge of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
  • Proven experience in therapeutic areas relevant to the company's pipeline.
  • Demonstrated ability to manage multiple clinical trials and sites simultaneously.
  • Excellent leadership, communication, and interpersonal skills.
  • Strong organizational and problem-solving abilities.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to work independently and collaboratively in a hybrid work environment.
  • Registered Nurse (RN) or equivalent clinical background is a plus.
  • Willingness to travel to clinical sites as required.
This is a significant opportunity to advance your career in clinical research within a leading pharmaceutical organization. If you are a results-driven professional with a passion for advancing medical treatments, we encourage you to apply.
Apply Now

Senior Clinical Research Associate (CRA)

53201 Milwaukee, Wisconsin $95000 Annually WhatJobs

Posted today

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Job Description

full-time
Our client, a leading pharmaceutical company dedicated to improving global health outcomes, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dynamic team. This role offers a hybrid work arrangement, combining remote flexibility with essential on-site collaboration. You will be responsible for monitoring clinical trials to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Key responsibilities include site initiation, routine monitoring, close-out visits, and ensuring the accuracy, completeness, and validity of clinical data. You will serve as the primary liaison between the clinical operations team and investigational sites, building strong relationships with investigators and site staff. The ideal candidate will possess a deep understanding of drug development processes and regulatory landscapes. You will conduct source data verification, review investigational product accountability, and ensure adherence to safety reporting procedures. This role demands exceptional attention to detail, strong organizational skills, and the ability to manage multiple sites and studies concurrently. You will also contribute to the training and mentorship of junior CRAs and participate in the development of study-related documents. Travel to investigational sites will be required, but a significant portion of your work can be performed remotely. Our client is committed to fostering a collaborative and innovative environment where your contributions are valued and recognized. You will play a critical role in bringing life-changing therapies to patients.

Responsibilities:
  • Conduct site visits (initiation, routine monitoring, close-out) to ensure protocol compliance and data integrity.
  • Verify source data against case report forms (CRFs) and electronic data capture (EDC) systems.
  • Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
  • Manage relationships with investigators, site staff, and study sponsors.
  • Oversee investigational product management and accountability at study sites.
  • Ensure timely and accurate submission of safety reports.
  • Review and approve site essential documents.
  • Provide training and support to site personnel.
  • Identify and resolve site-level issues and deviations promptly.
  • Contribute to the development of clinical trial protocols and study plans.
  • Mentor junior CRAs and participate in team meetings.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related field. Advanced degree preferred.
  • Minimum of 5 years of experience as a Clinical Research Associate.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Proven experience with EDC systems and clinical trial management software.
  • Excellent communication, interpersonal, and organizational skills.
  • Ability to travel up to 60% for site visits.
  • Strong problem-solving and decision-making abilities.
  • Experience in therapeutic areas relevant to our client's pipeline is a plus.
This role is based in Milwaukee, Wisconsin, US , with a hybrid work model.
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Senior Clinical Research Associate (Pharmaceuticals)

53201 Milwaukee, Wisconsin $100000 Annually WhatJobs

Posted 6 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a seasoned Senior Clinical Research Associate (CRA) to join their dynamic team. This role offers the flexibility of being fully remote, allowing you to contribute to groundbreaking clinical trials from anywhere within the US. You will play a pivotal role in ensuring the quality, integrity, and timely completion of clinical research studies, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements.

As a Senior CRA, you will be responsible for monitoring clinical trial sites, verifying data accuracy, and ensuring subject safety. Your expertise will be crucial in site selection, initiation, routine monitoring, and close-out activities. You will serve as the primary liaison between the sponsor and investigative sites, fostering strong relationships and facilitating effective communication. This position requires a deep understanding of clinical research processes, excellent organizational skills, and a commitment to scientific rigor.

Responsibilities:
  • Conduct site selection, initiation, routine monitoring, and close-out visits for clinical trial sites.
  • Verify the accuracy and completeness of clinical trial data by reviewing source documents against case report forms (CRFs).
  • Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and study-specific protocols.
  • Identify, track, and resolve site-related issues, escalating where necessary.
  • Educate and train site staff on study procedures, protocol requirements, and regulatory compliance.
  • Manage relationships with investigators and site personnel, providing support and guidance.
  • Oversee study budgets and timelines at the site level.
  • Prepare and present monitoring visit reports.
  • Participate in the development and review of study-related documents.
  • Stay updated on industry best practices and regulatory changes in clinical research.
  • Mentor junior CRAs and contribute to team knowledge sharing.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related field. Advanced degree is a plus.
  • Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
  • Extensive knowledge of GCP guidelines and regulatory requirements for clinical trials.
  • Proven experience in monitoring various phases of clinical trials (Phase I-IV).
  • Strong understanding of medical terminology and clinical trial procedures.
  • Excellent organizational, time management, and problem-solving skills.
  • Outstanding written and verbal communication skills, with the ability to build rapport with site staff.
  • Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Ability to travel as needed (though this role is primarily remote-focused, occasional site visits may be required).
  • Demonstrated ability to work independently and as part of a remote team.
This is a fully remote position supporting clinical trials, with a nominal base in Milwaukee, Wisconsin, US , offering an excellent opportunity for experienced CRAs seeking flexibility and impact.
Apply Now

Clinical Research Associate II - Pharmaceutical

53201 West Milwaukee, Wisconsin $75000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a prominent pharmaceutical company dedicated to advancing medical treatments, is seeking a diligent and experienced Clinical Research Associate II (CRA II) to join their team in Milwaukee, Wisconsin, US . This role is essential for ensuring the successful execution of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory standards. The CRA II will be responsible for site selection, initiation, monitoring, and close-out visits to ensure data integrity, patient safety, and protocol compliance. This position requires a strong understanding of clinical trial processes, excellent communication skills, and the ability to travel to clinical sites as needed.

Key Responsibilities:
  • Perform site selection, qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols and standard operating procedures (SOPs).
  • Ensure clinical trial conduct adheres to GCP, FDA regulations, and other applicable guidelines.
  • Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and case report forms (CRFs).
  • Monitor patient safety and report adverse events promptly as required.
  • Train and support site staff, ensuring protocol compliance and proper study conduct.
  • Maintain accurate and organized study documentation, including regulatory binders and site files.
  • Manage communication between study sites, the sponsor, and other stakeholders.
  • Identify and resolve site-level issues and escalate critical problems to the study lead or project manager.
  • Participate in investigator meetings and provide feedback on study progress.
  • Contribute to the development and review of study-related documents, such as protocols, informed consent forms, and monitoring plans.
  • Ensure timely query resolution and data management activities.

Qualifications:
  • Bachelor's degree in a life science, nursing, or a related field.
  • A minimum of 2-4 years of direct experience as a Clinical Research Associate, with demonstrated experience in monitoring clinical trials.
  • Solid understanding of GCP, ICH guidelines, and relevant regulatory requirements (e.g., FDA).
  • Experience with various therapeutic areas is a plus.
  • Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a team.
  • Willingness to travel up to 50-60% to clinical sites, primarily within the assigned region.
  • Valid driver's license and passport are required.
This is a fantastic opportunity to contribute to groundbreaking pharmaceutical research and development in Milwaukee, Wisconsin, US .
Apply Now
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Senior Clinical Research Associate (CRA)

53201 West Milwaukee, Wisconsin $105000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is actively recruiting a Senior Clinical Research Associate (CRA) to support their critical research initiatives in Milwaukee, Wisconsin, US . This position requires a meticulous and experienced professional to ensure the smooth execution and integrity of clinical trials. You will be responsible for site selection, initiation, monitoring, and close-out visits to ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. The Senior CRA will maintain effective communication with investigators, study coordinators, and internal project teams, addressing any study-related issues promptly and professionally. Key duties include reviewing and verifying case report forms (CRFs), source documents, and other study records to ensure data accuracy and completeness. You will also be involved in training site personnel on study procedures and protocol requirements. Travel to clinical sites, both domestic and potentially international, will be a significant component of this role. The ideal candidate will possess a strong understanding of clinical trial processes, from early phase development through to regulatory submission. Excellent organizational, problem-solving, and decision-making skills are essential. You must have the ability to work independently, manage multiple priorities, and meet strict deadlines. A bachelor's degree in a life science, nursing, or related field is required, along with significant prior experience as a CRA. Experience in specific therapeutic areas such as oncology, cardiology, or neurology is a strong asset. This role offers a challenging yet rewarding opportunity to contribute to the development of life-saving medicines and advance your career within a reputable pharmaceutical organization. The position offers a competitive salary and benefits package, along with opportunities for professional growth and development.
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Clinical Research Associate III - Pharmaceutical

53201 West Milwaukee, Wisconsin $95000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is looking for an experienced Clinical Research Associate III to join their dedicated clinical development team. This role involves contributing to the successful execution of clinical trials, ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. The ideal candidate will have a strong background in clinical trial monitoring, data management, and site management. You will be responsible for ensuring the quality and integrity of clinical trial data, managing investigational sites, and facilitating smooth trial progress.

Key Responsibilities:
  • Monitor clinical trial sites to ensure adherence to protocol, GCP, and applicable regulations.
  • Perform site initiation, interim, and close-out visits.
  • Verify the accuracy, completeness, and validity of clinical trial data through source data verification.
  • Manage investigational product accountability and investigational site supplies.
  • Develop and maintain strong working relationships with investigators, site staff, and study sponsors.
  • Ensure timely reporting of adverse events and serious adverse events.
  • Prepare and present study progress reports to project teams and management.
  • Assist in the selection and qualification of new clinical trial sites.
  • Manage study documentation and ensure the Trial Master File (TMF) is up-to-date and complete.
  • Participate in the development and review of clinical trial protocols, case report forms (CRFs), and other study-related documents.
  • Identify potential risks and issues at study sites and implement corrective and preventive actions (CAPAs).
  • Train site personnel on study-specific procedures and requirements.
  • Contribute to the development and implementation of departmental SOPs.
  • Provide support for regulatory inspections and audits.
  • Communicate effectively with internal teams and external stakeholders regarding trial status and any necessary actions.
This hybrid role requires a proactive and detail-oriented professional who can manage multiple priorities effectively. The ability to work both independently and as part of a collaborative team is crucial. Our client offers a stimulating work environment with opportunities for professional growth and development in the pharmaceutical industry. Employees are expected to be on-site for specific project needs, team meetings, and collaborative sessions, while also benefiting from the flexibility of remote work for other tasks.
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Senior Clinical Research Associate (CRA)

53202 West Milwaukee, Wisconsin $110000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a leading contract research organization (CRO) dedicated to advancing global health through innovative clinical trials, is seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to join their expanding team in Milwaukee, Wisconsin, US . This role is instrumental in ensuring the successful execution of clinical trials by overseeing site management, monitoring trial conduct, and ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will be responsible for site selection, initiation, routine monitoring, and close-out activities for clinical trial sites. The ideal candidate will possess a strong understanding of therapeutic areas and clinical trial processes, demonstrating meticulous attention to detail and exceptional organizational skills. Your responsibilities will include ensuring data integrity, subject safety, and compliance with all study-related procedures. You will serve as the primary point of contact for study sites, providing training, support, and guidance to investigators and site staff. Proactive identification and resolution of site-level issues are crucial. This position involves significant travel to clinical sites within your assigned region. While primarily focused on site engagement, a hybrid work model allows for a balance between on-site visits and remote administrative tasks, offering flexibility while maintaining strong site relationships in Milwaukee, Wisconsin, US and surrounding areas.

Key Responsibilities:
  • Perform site selection, initiation, routine monitoring, and close-out visits for clinical trial sites.
  • Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and regulatory requirements (e.g., GCP, FDA).
  • Verify the accuracy, completeness, and integrity of clinical data at study sites.
  • Monitor subject safety and ensure adverse events are reported according to protocol.
  • Build and maintain strong working relationships with investigators and site staff.
  • Provide training and ongoing support to study sites.
  • Resolve site-level issues and discrepancies promptly and effectively.
  • Prepare comprehensive monitoring visit reports and follow-up on action items.
  • Ensure timely retrieval of essential documents from study sites.
  • Contribute to the development and review of study-related documents.
  • Manage study sites to ensure adherence to timelines and budget.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related field.
  • Minimum of 5 years of experience as a Clinical Research Associate (CRA).
  • Extensive knowledge of GCP guidelines and regulatory requirements for clinical trials.
  • Proven experience in site monitoring, management, and auditing.
  • Strong understanding of clinical trial processes and data management.
  • Excellent interpersonal, communication, and organizational skills.
  • Ability to travel frequently (up to 60%) to clinical sites.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Demonstrated ability to work independently and manage multiple priorities.
  • Detail-oriented with a commitment to data quality and subject safety.
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