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Study Lead (Clinical Operations - Pharma Research & Early Development)

Little Falls NJ, NJ 07424

Posted: 03/21/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 552771 Is job remote?: No Country: United States

Job Description

Doing now what patients need next
We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

In Clieny Pharmaceutical Research and Early Development (pRED) we believe that rapid and innovative advances in science, technology, digital and big data are our greatest opportunities. We are passionate about improving the lives of patients and we strive for ambitious ideas, innovative approaches and urgent action. Together we create a culture defined by curiosity, responsibility and humility where our people are empowered and encouraged to bring forward extraordinary life-changing innovation.

Our North Star is to increase R&D Productivity and Patient Centricity. This is supported by our CO Strategy to deliver value for pRED CO, pRED BHAGs and our portfolio. We aspire to be a leading edge Clinical Operations organisation that drives innovative patient-centric approaches in study design and execution, utilizes advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to improve productivity delivery of programs and studies. We strive to create an inclusive workplace where team members own their own development and learning and are empowered to create and innovate.

The role of the Study Lead (SL) is to provide leadership for one or more global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man thru Proof of Concept studies. The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines.

DRIVE STUDY STRATEGY by designing study strategy, integrating the patient voice, driving diversity in enrollment, reviewing/contributing and evaluating executability of study protocol, country selection and data delivery plan, in partnership with cross-functional stakeholders. May be asked to contribute to the strategic development plans occasionally
LEAD STUDY TEAMS by providing the operational expertise and thought leadership as a leader of study teams that are accountable for delivering clinical studies; creating and driving study timelines, milestones and budget
MANAGE RISK AND COMPLIANCE by identifying, managing and mitigating risks and issues while ensuring the study team is trained on and adheres to all appropriate standards, including ICH/GCP, SOPs and other regulations
MANAGE VENDOR PERFORMANCE by providing direction and oversight for outsourced activities to ensure CRO and vendor delivery against contracted scope of work
INNOVATE AND CHAMPION CHANGE by driving process improvement, implementing new technologies and participating in supplemental non-project work – e.g., participate in cross-functional initiatives, attend and participate in conferences, ad boards

In Clinical Operations Mindset and behaviour is as important to us as skills and capabilities

Systems thinking
-Connect with the bigger picture, prioritize Client, pRED or wider team over Function and individual, apply enterprise view
-Collaborative and creative mindset, ability to partner inside and outside Client

Show and embrace agile behavior
-Follow a logic of incrementally improving approaches and solutions (80/20 approach where applicable/ Minimal Viable Products/ iterate)
-Stand in the shoes of stakeholders and able to build strong customer relationships
-Ability to cope with uncertainty and manage ambiguity

Empowerment and accountability
-Take ownership and accountability
-Empower people to contribute according to their skills, capacity and interest
-Decisions are made by the most appropriate person on the topic
-Foster a speak-up culture

Demonstrate a growth mindset
-Give, seek and receive constructive feedback
-Openly and proactively share information, failure, ideas, experience and learnings with others
-Drive innovations and foster the power of experimentation

Create value in an agile organization by increasing our focus on playing the role of Visionary, Architect, Coach and Catalyst
-As a visionary, you facilitate the creation of a bold, shared vision and higher purpose that is co-created with customers to advance a vision.
-As an Architect, you seek value creation across the whole organisation, shaping organisational architecture and culture.
-As a Coach you help everyone in the network build the skills and mindsets they need to succeed in an empowered system, acting as a role model and coach, with a willingness to be coached.
-As a Catalyst you help connect others' work to a collective purpose, creating connections and collaboration across the organisation.

You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit.
Have a growth mindset and are excited about learning through experience
Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments
Have sound experience in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus)
Hold a university degree or equivalent years of experience, preferred focus in life sciences
Find passion in achieving successful outcomes by leading, coaching and inspiring others
Want to make a difference and find excitement in innovating practices, therapeutics and processes
Possess strong working knowledge of drug development process and respective regulations
Feel comfortable traveling internationally based on specific program needs
Advocate for what you and your team need to succeed
Have a sound understanding and appreciation of the scientific basis for different study types, with the ability to question scientific rationale and practical aspects of protocol design

97-107 pay rate range
**salary will be commensurate with experience**
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