Study Start Up Lead - East Hanover, United States - Novartis

Novartis
Novartis
Verified Company
East Hanover, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Summary:


Posting Title:

Study Start Up Lead Remote About the role: (Editable Section unique to each role) The Study Start-Up (SSU) Lead plans and drives global SSU activities 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 Lead works collaboratively with other key CTT members and leads the SSU Team (CTT sub-team) 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.

Contributes 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.) - Prepares 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) - Implements global aspects of protocol and OEP amendments, activates and is responsible for country implementation of amendments as determined per trial and in conjunction with Study Leader.


Leads Global SSU Activation:

  • Ensures timely collection 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
  • Supports the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents
  • Ensures Protocol and ICF (Informed Consent Form) global trial template is ready for country usage as necessary including translations
  • Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency
  • Directs the Study Grants Expert for investigator grant plan/fair market value assessment initiation and finalization of country site budget and contract template readiness in conjunction with protocol timelines

About the Role:


Role Requirements:


  • Advanced degree or combination Bachelor's Degree with equivalent experience
A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable

  • Minimum 2 years' experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
  • Minimum 1 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, driving, 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.
  • Excellent communication, influencing and negotiating skills
  • Good knowledge of Good Clinical Practice, clinical trial setup design and global drug development process
  • Demonstrated effective influencing and negotiation skills at all levels.


The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.


Why 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


Commitment 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 $130,400-195,600/year; _however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to p
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