Study Start Up Lead

2 weeks ago

East Hanover, United States Novartis Full time

**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 set-up 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

  • Study Start Up Cra

    4 weeks ago

    East Hanover, United States Novartis Full time

    389802BR **Study Start Up CRA**: USA **About the role** (This is a Remote Position) Site relationship management role to ensure sustainable trial start-up at Site. The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and results of assigned sites for Phase I-IV GDD trials within the country in adherence...

  • Study Leader

    2 weeks ago

    East Hanover, United States Novartis Full time

    **About the Role**: Responsible with per needed-basis oversight from the Study Director community Lead (SD-CL) for the execution and delivery of the GCO supported clinical studies of standard to medium complexity and priority per the Operational Execution Plan (OEP) and clinical study protocol. The Senior Study Leader is the leader of the cross-functional...

  • Associate Director, Study Management

    4 days ago

    Hanover, United States CSL Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. If your skills, experience, and qualifications match those in this job overview, do not delay your...

  • Expert Vendor Program Manager

    2 weeks ago

    East Hanover, United States Novartis Full time

    **About the Role**: Core member of the Clinical Trial Team (CTT), independently handling all clinical vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager...

  • Expert Vendor Program Manager

    1 month ago

    East Hanover, United States Novartis Full time

    394018BR **Expert Vendor Program Manager**: USA **About the role** Core member of the Clinical Trial Team (CTT), independently handling all clinical vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level....

  • Immediate Opportunity: Packaging Engineer

    6 days ago

    East Hanover, United States The Fountain Group Full time

    Currently I have an opening for aPackaging Engineer located in East Hanover, NJ (Onsite). Details for the position are as follows:Job Description: Act as Packaging leader on medium and high complexity Candy, Cough and Chocolate projects, releasing packaging material specifications, supplier development, pilot and industrial trials, feasibility studies for...

  • Immediate Opportunity: Packaging Engineer

    7 days ago

    East Hanover, United States The Fountain Group Full time

    Currently I have an opening for aPackaging Engineer located in East Hanover, NJ (Onsite). Details for the position are as follows: Job Description: Act as Packaging leader on medium and high complexity Candy, Cough and Chocolate projects, releasing packaging material specifications, supplier development, pilot and industrial trials, feasibility studies for...

  • Packaging Engineer

    5 days ago

    East Hanover, United States TTI of USA, Inc. Full time

    Job Description: Act as Packaging leader on medium and high complexity Candy, Cough and Chocolate projects, releasing packaging material specifications, supplier development, pilot and industrial trials, feasibility studies for project implementation at the facilities, supporting product development, margin management and quality improvement projects. Being...

  • Packaging Engineer

    4 days ago

    East Hanover, United States TTI of USA, Inc. Full time

    Job Description: Act as Packaging leader on medium and high complexity Candy, Cough and Chocolate projects, releasing packaging material specifications, supplier development, pilot and industrial trials, feasibility studies for project implementation at the facilities, supporting product development, margin management and quality improvement projects....

  • Postdoctoral Research Associate in Environmental Studies: Modeling Agroforestry Transitions in ...

    7 days ago

    Hanover, United States InsideHigherEd Full time

    Postdoctoral Research Associate in Environmental Studies: Modeling Agroforestry Transitions in New EnglandLocation:Hanover, NHOpen Date:Feb 7, 2024Description:The Ong Agroecology Lab in the Department of Environmental Studies (ENVS) at Dartmouth College invites applications for a postdoctoral researcher specializing in spatial ecology and theory of...

  • Retail Sales Lead Golf

    6 days ago

    East Hanover, United States DICK'S SPORTING GOODS INC Full time

    At DICK’S Sporting Goods, we believe in how positively sports can change lives. On our team, everyone plays a critical role in creating confidence and excitement by personally equipping all athletes to achieve their dreams. We are committed to creating an inclusive and diverse workforce, reflecting the communities we serve.If you are ready to make a...

  • Retail Sales Lead Team Sport

    4 days ago

    East Hanover, United States DICK'S SPORTING GOODS INC Full time

    Dick's Sporting Goods Retail Sales Lead Team Sport East Hanover , New Jersey Apply Now At DICK’S Sporting Goods, we believe in how positively sports can change lives. On our team, everyone plays a critical role in creating confidence and excitement by personally equipping all athletes to achieve their dreams. We are committed to creating an inclusive and...

  • Retail Sales Lead Golf

    6 days ago

    East Hanover, United States DICK'S SPORTING GOODS INC Full time

    At DICKS Sporting Goods, we believe in how positively sports can change lives. On our team, everyone plays a critical role in creating confidence and excitement by personally equipping all athletes to achieve their dreams. We are committed to creating an inclusive and diverse workforce, reflecting the communities we serve. If you are ready to make a...

  • Team Lead, Patient Navigator

    2 weeks ago

    East Hanover, United States Novartis Full time

    **Summary**: **About the Role**: Key Responsibilities: - Lead a team of 12-14 customer-facing Patient Navigators with responsibility handling all aspects of patient case navigation (start form intake, benefits check, prior authorization and appeals, etc.). This work will focus on one or more of Novartis’s specialty brands - Oversee the case management...

  • Retail Sales Lead Golf

    6 days ago

    East Hanover, United States DICK'S Sporting Goods Full time

    At DICK’S Sporting Goods, we believe in how positively sports can change lives. On our team, everyone plays a critical role in creating confidence and excitement by personally equipping all athletes to achieve their dreams.  We are committed to creating an inclusive and diverse workforce, reflecting the communities we serve.If you are ready to make a...

  • Associate Director Lead for Data Steward

    4 weeks ago

    East Hanover, United States Saviance Technologies Full time

    The primarily functional/business lead and will have some technical /Analyst type skills to roll up the sleeves and look into the data as needed. Strong experience in data operations - new data source/data sets onboarding, identifying and implementing data quality checks, and driving E2E data quality Manage a team data stewards, establish clear...

  • Clinical Operations Program Manager

    2 weeks ago

    East Hanover, United States Novartis Full time

    **Summary**: Onsite - East Hanover About the role: The Clinical Operations Program Manager (COPM) will provide operational support for clinical development programs and trials where there are early viability, feasibility, allocation and site selection activities to deliver. The scope of activities for this key role will range from early viability,...

  • Services Lead

    2 weeks ago

    Hanover, United States MoveAmerica.org Full time

    MoveAmerica is seeking a Strategic Response Cell (SRC) Services Lead who will play a crucial role, supporting the DoD Office of Small Business Programs specifically assisting with the execution and management of Mentor Protégé Program (MPP) directed initiatives as the MPP Intermediary within the Office of Small Business Programs. The Ideal candidates will...

  • Services Lead

    2 months ago

    Hanover, United States MoveAmerica.org Full time

    MoveAmerica is seeking a Strategic Response Cell (SRC) Services Lead who will play a crucial role, supporting the DoD Office of Small Business Programs specifically assisting with the execution and management of Mentor Protégé Program (MPP) directed initiatives as the MPP Intermediary within the Office of Small Business Programs. The Ideal candidates will...

  • Services Lead

    1 month ago

    Hanover, United States MoveAmerica.org Full time

    MoveAmerica is seeking a Strategic Response Cell (SRC) Services Lead who will play a crucial role, supporting the DoD Office of Small Business Programs specifically assisting with the execution and management of Mentor Protégé Program (MPP) directed initiatives as the MPP Intermediary within the Office of Small Business Programs. The Ideal candidates will...