Senior Project Manager / Project Manager - Oncology, Early Phase

Location: United States, home-based - EST and CST locations preferred

Your experience as a seasoned Clinical Project Manager with a passion for precision and a knack for exceptional customer service has garnered you a reputation for success. You possess a track record of dedication, clinical expertise, and overseeing clinical trials with finesse ensuring they remain on track from inception to completion at a high level of service from the CRO perspective.

If this is you, we invite you to use your naturally proactive, and inquisitive mind to learn more about KCR at the link below and look forward to hearing from you.

As a Clinical Project Manager at KCR, you will leverage your extensive clinical knowledge to navigate regulatory landscapes and maintain compliance, all while fostering strong client relationships through unparalleled service. If you thrive in a dynamic environment, possess meticulous attention to detail, and excel in delivering results while exceeding client expectations, we want to connect with you.

Join us in shaping the future of clinical research and making a meaningful impact on patient outcomes.

We see human behind every number.

Main Requirements:

• 8 years of clinical professional experience in the CRO and/or biotech setting
• 4 years of full-service PM experience;
• Clinical (CTM, with previous CRA) background preferred;
• Global clinical study experience will be an asset
• University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Strong team leadership skills;
• Ability to build solid external relationships and motivate a regional or global team;
• Strong decision-making skills;
• Excellent presentation skills;
• Fluent in local office language and strong in English, both written and verbal;
• Available for travel up to 20% of the time.

Main Responsibilities:

• Takes full leadership on all project deliverables on projects assigned as global PM (fulfils the role of regional PM on given project for specific countries, if business demands);
• Ensures that project deliveries are on time, within budget and with quality;
• Builds and manages the study budget, implement actions to mitigate areas of risk, drive delivery across the full project, collaborate with internal stakeholders to track study progress and create study tools. Oversees study budgets development across program as required;
• Analyzes Study Protocol (or study assumptions and Sponsor’s needs in case Protocol is not available), in order to define scope of services for internal and external Providers project success and identify risks from the beginning of the project;
• Coordinates and manages project start-up, project maintenance, and project close-out activities;
• Provides leadership to KCR study team members as well as relevant vendors;
• Sets up all relevant study plans and keeps them updated throughout the study execution;
• Communicates updates to project scope and/or timelines to all parties involved;
• Leads teleconferences and meetings with Sponsor, Services Providers and Managers from other departments;
• Maintains study status tracking tools up to date and drives team member’s compliance;
• Proactively communicates project status, issues & risks to stakeholders and management;
• Coordinates work of services providers, transparently communicating to the Sponsor all decisions and deviations related to Service Providers (e.g. CRO, EDC provider, Central Laboratory, Investigators;
• Closely collaborates with Project Finance Management in the project finance oversight and addresses issues/incompliances immediately until resolution. This includes but is not limited to: verification of budget offer, accurate reporting of study costs by Services Providers, overseeing value of pass-through costs and CRO remuneration, reacting immediately to deviations or changes that may have impact on budget realization and proposing Change Order, controlling financial aspects of projects within assigned project portfolio;
• Participates actively in preparation and conduct of Bid Defense Meetings;
• Leads activities in Investigators Meeting preparation and conducts it; agrees on meeting agenda and the list of presentations, participates in the meeting as a host and presenter;
• Provides mentoring to APL/PLs and Project Managers;
• Performs Site Engagement visit to assigned country in line with CCOS strategy;
• Participates in sponsor audits and Regulatory Authority inspections;
• Performs other duties as assigned by Line Manager.

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.

To demonstrate how appreciated your talent and your commitment are, KCR is offering you:

• 33 PTO days 1 additional day for your birthday
• A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs
• Onboarding process and induction trainings to develop deep sector knowledge and complex skills;
• Latest technology and the most advanced equipment and working tools;
• An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement;
• Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills;
• Flexible hybrid working model (remote/home office).

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25 countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

Our Privacy Policy

Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: KCR Privacy Policy.

Equal Opportunity Employer

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

If you require reasonable accommodations to participate in the application process, please let us know by email: eeo@kcrcro.com. We are committed to ensuring equal opportunity for all applicants and will work to provide reasonable accommodations to support your needs.

By applying to this position, applicant acknowledges that they have been provided with the above company policies, as well as applicable state and federal regulations and permit contact by the KCR Talent Acquisition team.

***This requisition is not open to solicitation - no agency contact***