Study Start-Up Senior Lead
About the roleLocation:
East Hanover, PreferredThe Study Start-Up (SSU) Senior Lead independently leads the planning and execution of global SSU activities for multiple medium to complex global studies of high priority to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
The Study Start-Up Senior Lead works collaboratively with other key Clinical Trial Team (CTT) members and leads the SSU Team (CTT sub-team / 20
members across multiple countries) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation.
Key
Responsibilities:
Early Planning and Team Leadership:
Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies.
Independent decisions for all study start-up activities.
Full responsibility to independently deliver SSU insights to the development of the trial, Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones, and dashboards with Study Leader /Clinical Trial Team (CTT).
Configures and ensures proper trial-specific set-up of SSU systems (e.
g.
, Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.
) Autonomously strategizes global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial)Leads Global SSU Activation:
Responsible for global trial level document readiness (including vendor and IMP (INVESTIGATIONAL MEDICINAL PRODUCT) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation.
Guides the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents.
Accountable for country SSU:
Coaches the country Study Start-up Managers to drive timely start-up activities from country allocation to Ready to Enroll within assigned medium to complex trials.
Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.
g.
IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe:
acc.
to new EU-CTR) as well as Health Authorities and adherence to process standards.
Guides the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.
Ensure global deliverables to enable site initiation readiness is in place for initial drug releaseThe ideal location for this role is East Hanover where hybrid working principles apply.
A distant working arrangement may be considered in certain states for US associates who are not within a daily commutable distance (more than 50 miles one way).
Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover, as determined necessary by hiring manager.
EEO Statement We are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Novartis:
e-mail us.
reasonableaccommodations@novartis.
com or call +1 (877)395-2339Sandoz:
e-mail reasonable.
accommodations@sandoz.
com or call:
+1-609-422-4098Role Requirements A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable.
Fluent English, spoken and written.
Minimum 6 years' experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
Minimum 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.
g.
, planning, executing, reporting, and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization.
Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.
Comprehensive experience in leading multidisciplinary teams in a complex matrix environmentWhy Novartis:
Helping people with disease and their families takes more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting and inspiring each other.
Combining to achieve breakthroughs that change patients lives.
Ready to create a brighter future together? https:
//www.
novartis.
com/about/strategy/people-and-culture Benefits and Rewards:
Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
https:
//www.
novartis.
com/careers/benefits-rewardsCommitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit
Summary:
The pay range for this position at commencement of employment is expected to be between $151,200 - $226,800/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.
Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
https:
//talentnetwork.
novartis.
com/networkDivisionDevelopment Business UnitGCO GDD Work LocationEast Hanover, NJ Company/Legal EntityNovartis PharmaceuticalsFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular Shift WorkNoEarly TalentNoCountry:
USA.
Estimated Salary: $20 to $28 per hour based on qualifications.
East Hanover, PreferredThe Study Start-Up (SSU) Senior Lead independently leads the planning and execution of global SSU activities for multiple medium to complex global studies of high priority to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
The Study Start-Up Senior Lead works collaboratively with other key Clinical Trial Team (CTT) members and leads the SSU Team (CTT sub-team / 20
members across multiple countries) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation.
Key
Responsibilities:
Early Planning and Team Leadership:
Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies.
Independent decisions for all study start-up activities.
Full responsibility to independently deliver SSU insights to the development of the trial, Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones, and dashboards with Study Leader /Clinical Trial Team (CTT).
Configures and ensures proper trial-specific set-up of SSU systems (e.
g.
, Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.
) Autonomously strategizes global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial)Leads Global SSU Activation:
Responsible for global trial level document readiness (including vendor and IMP (INVESTIGATIONAL MEDICINAL PRODUCT) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation.
Guides the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents.
Accountable for country SSU:
Coaches the country Study Start-up Managers to drive timely start-up activities from country allocation to Ready to Enroll within assigned medium to complex trials.
Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.
g.
IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe:
acc.
to new EU-CTR) as well as Health Authorities and adherence to process standards.
Guides the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.
Ensure global deliverables to enable site initiation readiness is in place for initial drug releaseThe ideal location for this role is East Hanover where hybrid working principles apply.
A distant working arrangement may be considered in certain states for US associates who are not within a daily commutable distance (more than 50 miles one way).
Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover, as determined necessary by hiring manager.
EEO Statement We are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Novartis:
e-mail us.
reasonableaccommodations@novartis.
com or call +1 (877)395-2339Sandoz:
e-mail reasonable.
accommodations@sandoz.
com or call:
+1-609-422-4098Role Requirements A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable.
Fluent English, spoken and written.
Minimum 6 years' experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
Minimum 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.
g.
, planning, executing, reporting, and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization.
Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.
Comprehensive experience in leading multidisciplinary teams in a complex matrix environmentWhy Novartis:
Helping people with disease and their families takes more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting and inspiring each other.
Combining to achieve breakthroughs that change patients lives.
Ready to create a brighter future together? https:
//www.
novartis.
com/about/strategy/people-and-culture Benefits and Rewards:
Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
https:
//www.
novartis.
com/careers/benefits-rewardsCommitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit
Summary:
The pay range for this position at commencement of employment is expected to be between $151,200 - $226,800/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.
Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
https:
//talentnetwork.
novartis.
com/networkDivisionDevelopment Business UnitGCO GDD Work LocationEast Hanover, NJ Company/Legal EntityNovartis PharmaceuticalsFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular Shift WorkNoEarly TalentNoCountry:
USA.
Estimated Salary: $20 to $28 per hour based on qualifications.
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