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Senior Study Leader (EG)

  • Clinical Operations
  • Clinical Research
  • Clinical Studies
  • Clinical Study
  • Clinical Trial
  • Clinical Trials
  • Documentation
  • Drug Development
  • FDA
  • GCP/ICH
  • Publishing
  • Therapeutic
Description:

This is a temporary contractor opportunity at Novartis 
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com 

 
Ready to work with/through Magnit at Novartis? Please read on... 
In planning for 2024, in the month(s) ahead, we anticipate hiring for this role:

Senior Study Leader
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 clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversee budget and people allocation within assigned study/studies.
Contribute in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.

Duties
1. Leads the Clinical Trial Team with per-needed basis oversight from the Study Director-
community Lead (SD-CL) and support from the Clinical Operations Program Head (COPH), delivery of multiple medium to complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and a team of teams' model
2. Acts as the CTT product owner with duties and responsibilities per established ways of working
3. Guides planning and decision making at the study level and delivers assigned clinical
study/studies per the Operational Execution Plan (OEP) and clinical study protocol
4. Fosters an agile culture within assigned studies to achieve sprint goals and cycles,
maximizing collaboration and minimizing dependencies to achieve long-term business
impact
5. In collaboration with regulatory writing and clinical development, promotes operational
excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
6. Create effective CTT dynamics and achieve on performance, prioritization, and
communication in close collaboration with CTT sub-team leaders
7. Proactive risk management and inspection readiness
8. Responsible for developing clinical study timelines with per needed-basis oversight from the Study Director-community Lead (SD-CL) and support from the Clinical Operations Program Head (COPH), and overseeing assigned study budgets
9.Ensures systems are maintained with up-to-date study status, risks, and issues
10. Fosters a close working relationship with SSO Clinical Project Managers (CPMs) to
strengthen the relationship between the global and local teams
11. Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Project Managers (CPMs)
12. Fosters a close working relationship with the VPG Vendor Program Managers (VPMs) to
strengthen the relationship between the vendors and CTT to deliver on clinical study objectives
13. Fosters a close working relationship with the CDO Trial Data Scientists (TDS) to deliver on clinical study objectives
14. Ensures proper handling of all study close out activities including but not limited to site
close out, final drug accountability and audit readiness of Trial Master File documentation
15. Promotes operational excellence and contributes to the development of Clinical Study
Reports, reporting of clinical trial results, and internal/external publications, when appropriate
16. May deputize for the Clinical Operations Program Head as a leader and spokesperson for the CTT at Novartis internal meetings
17. Partners and collaborates with PSPCOPH to deliver clinical studies in alignment with program strategy
18. Play a key role in achieving excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead/Host and GCO Process, Training, and Compliance (PTC)
CTT Coaching and Resource Management
1. Partners and collaborates with functional line leadership to ensure optimal people stafing of the study team
2. Build high-performing teams and create an empowered psychologically safe culture to foster high performance in a matrix environment
Serves as the single point of contact as the SSO Representative in the CTT for internal/external customers.

Community participation
1.Active member of a community(ies) as a citizen within the study leadership organization
2.Apply and encourage new CTT mindset, values, and principles; be a catalyst for these CTT ways of working (incl agile).

Experience/Professional requirements:
• 4 + years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority
• 3+ years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Experience in managing people globally in a complex matrix environment preferred
•Management of virtual teams. Proven ability and strong experience leading teams and building capabilities
•Experience in developing effective working relationships with internal and external stakeholders
•Excellent communicator and presenter (oral and written); Ability to communicate at all levels
•Excellent organization and prioritization
•Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions for SSO and GCO/GDD
•Strong Project Management skills and demonstrated ability to meet timelines
•Proven track record in trial operations process improvement(s) in some aspects of clinical trials
•Superior strategic thinking with strong analytical and problem-solving skills
•Knowledge of appropriate therapeutic area strongly preferred.

Location: East Hanover, NJ (Hybrid Schedule/Preferred)
Pay Rate:  $100- $119/hour
Contract: 11+ months
Health, dental, vision, 401k

Why Novartis? 
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. 
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. 
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! 
Imagine the impact you could make here at Novartis! 

Commitment to Diversity & Inclusion: 
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. 
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all. 

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com or 1.862.778.5441. 

Commitment to Diversity and Inclusion / EEO

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen, Other valid work visa
  • Preferred years of experience : 3+ Years
  • Travel Required : No travel required
  • Shift timings: East Hanover, NJ (Hybrid Schedule/Preferred)
Job Location
East Hanover, New Jersey
Pay
USD 100.00 - USD 119.00 Per Hour
CONTRACT DURATION
10 month(s)
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