Clinical Project Manager Ii

Clinical Project Manager II - Oncology, Early Phase

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

Your experience as a well-versed Clinical Project Manager with a passion for precision and a knack for exceptional customer service has garnered you a solid foundation as a Clinical Project Manager or Senior Clinical Trial Manager ready for your next transition. You possess a solid track record of dedication, clinical expertise, relationship building, management, and oversight of 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 II at KCR, you will leverage your 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, are motivated with 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:

• 5+ years of clinical professional experience in the CRO and/or biotech setting
• 4+ years of Clinical Trial Management experience;
• Clinical (CTM, with previous CRA) background preferred;
• 2+ years recent experience in Therapeutic area of Oncology, Phase I clinical trials
• 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);
• Basic Drug Development knowledge
• Managed at least 2 project phases as a PM (start-up, recruitment, maintenance, close-out, archival)
• Strong team leadership skills;
• Ability to build solid external relationships and motivate a regional or global team;
• Managed sites in at least 2 geographic regions
• Managed at least 1 external vendor
• 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. Including overnight stays, local and international as needed.

Main Responsibilities:

• Full accountability for all aspects of the clinical study; may delegate tasks as needed.
• 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;
• Developing, reviewing, and set up all relevant study plans and keeps them updated throughout the study execution;
• Reading and understanding the entire Clinical Protocol, identifying key Clinical risks
• Internal and external study status reporting
• Advising clients on study delivery strategies
• Leading Client and Investigator Meetings
• Developing the Clinical Monitoring Plan, reviewing and updating approved plan
• Managing Investigational Product, Blinding/Unblinding activities and recruitment for the assigned regions and/or the entire study (if assigned as Lead PM)
• Monitoring oversight across regions
• Regularly reviewing and categorization of Protocol Deviations; developing, reviewing, and updating the Protocol Deviation Handling Plan
• Managing and driving all start-up, maintenance, and close-out activities in all project phases
• Participating in audits and inspections
• Performing Site Engagement Visits, as applicable
• Managing all aspects of external vendors
• Collaborating with Project Finance at project level
• Keeping oversight and driving resolution of project issues
• Identifying areas for improvement initiatives and participating in them
• Following Standard Operating Procedures (SOPs) and driving compliance of others
• Provides mentoring to APL/PLs and Project Manager I;
• Assuring compliance with assigned project trainings (own and team); developing and delivering trainings to project team
• Supporting preparation of Bid Defense Meetings
• 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.

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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***