Clinical Project Manager

323373BR
Jul 13, 2021
Czech Republic

Job Description

Clinical Project Manager, Novartis, Prague, Czech Republic

108,000 people of more than 140 nationalities work at Novartis around the world. NBS CONEXTS is an internal service organization and provides clinical project management services to a variety of Novartis customers. These may range from CPM working within a customer team to CPM leading a study that has been fully outsourced to NBS CONEXTS.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Lead and handle a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.). And support the Sr. CPM where applicable
• Responsible for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence
• Directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up. Also smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution
• In collaboration with the NBS CONEXTS or Customer data review team (Central data Monitors, Data Managers, Statisticians, and third parties), contribute to the study data ongoing medical/scientific quality review to ensure high quality data are transferred/available in a timely manner.
• Coordinate the data analysis and interpretation for first interpretable results (where applicable) with the NBS CONEXTS or Customer Medical Representative
• Responsible for Clinical Study Report, either directly contributing to or running the report writing, or by liaising with the NBS CONEXTS or customer medical writing/narrative group
• In partnership with Clinical Operations Specialists (COS) responsible for the set up and maintenance of the Trial Master File (TMF) and Clinical Trial Management System (CTMS) for studies
• Work with CTT and QA to identify potential issues and implement actions to resolve them

Minimum Requirements

What you’ll bring to the role:
• Advanced degree or equivalent education/degree in life science/healthcare is required
• 8 years’ Clinical Operations experience, preferably with at least 2 years managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or clinical research organization
• Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process
• Demonstrated presentation skills, diplomacy skills; negotiation and conflict resolution skills, strong customer oriented attitude and the ability to resolve issues with minimal direction and understand when to escalate
• Proven track record to work independently in a sophisticated matrix environment (including remote) as well as ability to work within the team; fluent English (oral and written)

You’ll receive:
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Edenred CZ in the amount of 12,500 CZK per year; Meal vouchers in amount of 90 CZK for each working day (full tax covered by company); Public Transportation allowance; MultiSport Card. Find out more about Novartis Business Services: https://www.novartis.cz/


Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, 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 our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

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

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
CTS
NBS CONEXTS
Czech Republic
Prague
Research & Development
Full Time
Regular
No
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323373BR

Clinical Project Manager

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