Study Start-Up Project Manager (Ethics and Regulatory Submissions)
Maidenhead | www.pharmiweb.jobs |
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are looking for a Study Start-Up Project Manager to be 100% home based anywhere in the UK.
This role would suit a Study Start-up specialist looking for a more senior & progressive role. This particular job will be 100% client dedicated with a global Pharmaceutical company.
The main responsibility will be management of multiple study 'Country level' Clinical Trial Applications and Maintenance tasks throughout their life cycle. This will include organization of initial applications and amendments to Competent Authorities and Ethics both within the UK via Combined Review and the Republic of Ireland via EUCTR application processes.
Production of essential documentation such as country level ICFs for approval will be required along with other tasks such as organization of drug delivery, support of relevant safety reporting, recording and maintenance of the eTMF accordingly to strict deadlines as applicable.
This position has a significant impact on how the UK can deliver country-specific trial commitments and objectives, especially during start-up.
Qualifications, Skills and Experience
Core competencies:
• Previous submissions experience is a MUST!
• Excellent English skills
• Strong coordination and organizational skills
• Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM
• Ability to make decisions independently with limited oversight from SCOM
• Requires strong understanding of local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Behavioral Competency Expectations:
• Problem solving is essential to this position.
• Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget/CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
Other Information:
This role is a full time position to be employed through Fortrea. For more information please contact Magdalena Kozłowska on Magdalena.Kozlowska@Fortrea.com.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are looking for a Study Start-Up Project Manager to be 100% home based anywhere in the UK.
This role would suit a Study Start-up specialist looking for a more senior & progressive role. This particular job will be 100% client dedicated with a global Pharmaceutical company.
The main responsibility will be management of multiple study 'Country level' Clinical Trial Applications and Maintenance tasks throughout their life cycle. This will include organization of initial applications and amendments to Competent Authorities and Ethics both within the UK via Combined Review and the Republic of Ireland via EUCTR application processes.
Production of essential documentation such as country level ICFs for approval will be required along with other tasks such as organization of drug delivery, support of relevant safety reporting, recording and maintenance of the eTMF accordingly to strict deadlines as applicable.
This position has a significant impact on how the UK can deliver country-specific trial commitments and objectives, especially during start-up.
Qualifications, Skills and Experience
Core competencies:
• Previous submissions experience is a MUST!
• Excellent English skills
• Strong coordination and organizational skills
• Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM
• Ability to make decisions independently with limited oversight from SCOM
• Requires strong understanding of local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Behavioral Competency Expectations:
• Problem solving is essential to this position.
• Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget/CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
Other Information:
This role is a full time position to be employed through Fortrea. For more information please contact Magdalena Kozłowska on Magdalena.Kozlowska@Fortrea.com.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
Don’t miss out on new job vacancies!
Create a job alert for: Safety Specialist, Maidenhead
It's free, and you can cancel email updates at any time