Study Start Up Cra

2 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 with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager
- Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and results are met according to country commitments
- Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
- Conducts site selection visits, verifies site eligibility for a specific study
- Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
- Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
- Facilitates the preparation and collection of site and country level documents
- Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines
- Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
- Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities

**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._

**Role Requirements**
- BS/BA Degree. Degree in scientific or healthcare discipline preferred
- Minimum 3 years’ experience in clinical operations in a monitoring / site management role
- Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Central/in-house monitoring or field monitoring experience is desirable
- Strong site management capabilities with demonstrated negotiating and problem-solving skills
- Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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 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.

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

East Hanover, NJ

**Company/Legal Entity**

Novartis Pharmaceuticals

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work*

  • Pool Service

    3 weeks ago

    East Hanover, United States Rix Pool Spa & Sauna Full time

    Job DescriptionJob DescriptionJob duties and responsibilities are generally described below.  ·         Load the service truck as directed ·         Prepare the swimming pool cover for removal.  Remove the cover.·         Drain, clean, roll-up, and store the water bags.  Replace the “pop-ups” for the cover.·         Clean,...

  • Senior Tax Analyst

    7 days ago

    East Hanover, United States Novartis AG Full time

    Summary The Senior Tax Analyst will be an integral part of the tax function. The Senior Tax Analyst will be responsible for federal and state income tax matters with a heavy focus on corporate compliance and reporting for US business units in close cooperation with other federal, state tax team members, tax controversy, tax planning, business unit...

  • Pool Service

    3 weeks ago

    East Hanover, United States Rix Pool Spa & Sauna Full time

    Job DescriptionJob DescriptionJob duties and responsibilities are generally described below. Load the service truck as directed Prepare the swimming pool cover for removal. Remove the cover. Drain, clean, roll-up, and store the water bags. Replace the pop-ups for the cover. Clean, sanitize and fold/roll the cover for storage. Place the cover in the...

  • Laboratory Assistant

    1 week ago

    East Hanover, United States Innovative Management Solution Full time

    **Job Title**:Laboratory Assistant **Job Location**:East Hanover, NJ 07936 **Position Type**:Contract (4 month duration) A 4-year degree in a science-related or similar technical field such as Food Science, Nutrition, or Science will be required. Some prior lab experience would be appreciated as well as an independent highly motivated and driven...

  • Laboratory Assistant

    1 week ago

    East Hanover, United States RM Dream Homes Pvt. Ltd. Full time

    **Job Title**:Laboratory Assistant **Job Location**:East Hanover, NJ 07936 **Position Type**:Contract (4 month duration) A 4-year degree in a science-related or similar technical field such as Food Science, Nutrition, or Science will be required. Some prior lab experience would be appreciated as well as an independent highly motivated and driven...

  • Formula Management Specialist

    3 weeks ago

    East Hanover, United States Givaudan Fragrances Full time

    Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and...

  • TMF Oversight Manager

    6 days ago

    East Hanover, NJ, United States Novartis Full time

    Job Description100,000 and more! That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide.But in this world of digital and technological transformation, we must also...

  • Sr Prin Clinical Data Scientist

    6 days ago

    East Hanover, NJ, United States Novartis Full time

    About the roleLocation: East Hanover, NJ #LI-HybridHiring for multiple roles. About the role: Love data management? Bring that passion to Novartis!This key Senior Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for...

  • Director of Project Management

    2 weeks ago

    Hanover, United States Wilkinson Ecological Design Inc Full time

    The Project Director (PD) oversees business development, acts as a technical resource to the design team, and supervises the project management department. Responsible for ensuring client satisfaction, regulatory compliance, and effective team collaboration. Principal Accountabilities: Applies technical expertise in ecological restoration and environmental...

  • Prin Clin Sci

    2 weeks ago

    East Hanover, NJ, United States Novartis Full time

    About the roleLove data management? Bring that passion to Novartis!Multiple openings.This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical...

  • Project Director

    15 hours ago

    Hanover, United States Wilkinson Ecological Design, Inc. Full time

    The Project Director (PD) oversees business development, acts as a technical resource to the design team, and supervises the project management department. Responsible for ensuring client satisfaction, regulatory compliance, and effective team collaboration.Principal Accountabilities:technical expertise in ecological restoration and environmental...

  • Project Director

    1 day ago

    Hanover, United States Wilkinson Ecological Design, Inc. Full time

    The Project Director (PD) oversees business development, acts as a technical resource to the design team, and supervises the project management department. Responsible for ensuring client satisfaction, regulatory compliance, and effective team collaboration.Principal Accountabilities:technical expertise in ecological restoration and environmental...

  • Custodian

    2 weeks ago

    Hanover, United States Dartmouth College Full time

    **Please see Special Instructions for more details.** Schedule: Saturday-Wednesday, 3.00pm-11.30pm; Thursday/Friday off UNION POSITIONS ARE AVAILABLE TO SEIU UNION MEMBERS ONLY DURING THE FIRST WEEK OF POSTING. AFTER ONE WEEK OF POSTING, IF THE POSITION HAS NOT BEEN FILLED INTERNALLY, IT IS OPEN TO THE GENERAL PUBLIC AND OTHER MEMBERS OF THE DARTMOUTH...

  • Custodian

    3 weeks ago

    Hanover, United States Dartmouth College Full time

    **Please see Special Instructions for more details.** Schedule: Saturday-Wednesday, 3.00pm-11.30pm; Thursday/Friday off UNION POSITIONS ARE AVAILABLE TO SEIU UNION MEMBERS ONLY DURING THE FIRST WEEK OF POSTING. AFTER ONE WEEK OF POSTING, IF THE POSITION HAS NOT BEEN FILLED INTERNALLY, IT IS OPEN TO THE GENERAL PUBLIC AND OTHER MEMBERS OF THE DARTMOUTH...

  • Anesthesia Technician

    1 week ago

    Hanover, United States UPMC Central PA Full time

    Performs a variety of duties related to and involving the processing and preparing of room, equipment and supplies for the patients undergoing anesthetic procedures. This position will cover on call each weekend for emergency cases. Responsibilities: Maintains anesthesia supplies and drugs by establishing inventory levels; requisitioning supplies and...

  • Anesthesia Technician

    3 days ago

    Hanover, United States UPMC Central PA Full time

    Performs a variety of duties related to and involving the processing and preparing of room, equipment and supplies for the patients undergoing anesthetic procedures. This position will cover on call each weekend for emergency cases. Responsibilities: Maintains anesthesia supplies and drugs by establishing inventory levels; requisitioning supplies and...

  • Jr. Product Manager/Sales Support

    2 weeks ago

    Hanover, United States Sturtevant Inc. Full time

    JR. Product Manager for Hanover, MA office. This individual will be responsible for providing sales support to our Product Managers and our network of Manufacturing Representatives (Reps). Additionally, this individual will learn all our product lines and be ready to step into the Product Manger role whenever an opportunity presents itself. This individual...

  • Jr. Product Manager/Sales Support

    2 weeks ago

    Hanover, United States Sturtevant Inc. Full time

    JR. Product Manager for Hanover, MA office. This individual will be responsible for providing sales support to our Product Managers and our network of Manufacturing Representatives (Reps). Additionally, this individual will learn all our product lines and be ready to step into the Product Manger role whenever an opportunity presents itself. This individual...

  • Entry Level Cook

    1 week ago

    Hanover, United States TrueBlue Full time

    We are looking for an Entry Level Cook to join our team in Hanover NH. As an Entry Level Cook, you will have the opportunity to learn and develop your culinary skills under the guidance of experienced chefs. This position is ideal for individuals who are passionate about food and eager to start their career in the culinary industry. We offer on-the-job...

  • Global Account Director

    4 weeks ago

    East Hanover, New Jersey, United States Talent Factor Ltd. Full time

    Job Description Lead account management for a large global consumer goods company.  Creatively translate Customer goals, priorities, company experience, and capabilities into deals.  Create and execute Account Management Plan that encompasses our position, direction, and strategic way forward with the Customer.  Proactively seeks for new stakeholders...