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. With growing operations in the United States this is an exciting time to join us as continue the success KCR has become known for in its 25 years of operations into a future continuing to propel forward with our mission to provide comprehensive solutions and focus driven support.

For more information we invite you to visit www.kcrcro.com

We see human behind every number - for us that is more than a motto, it's the approach we look for in our Clinical Team Manager - both to the internal talent of our team, and how to identify, guide, and bring out the talent in our CRAs and in our approach to solutions always mindful that at the heart of clinical trials, it's the patients we all serve.

Clinical Team Manager

Location: US (home-based) - EST or CST Time zones Preferred

This exciting and unique role could take you to the next step of your career within clinical research.

You will have a great opportunity to progress your career in line management. If leadership, efficiency, and effective operations are your passion, we want to talk with you!

We are seeking high performing individuals who enjoy a challenging and fast-paced environment, who are proactive, motivated and open minded.

Sounds like you?

At KCR, you will be empowered to develop your career with a tailored onboarding, training and mentoring.

Responsibilities:

• Direct oversight, performance management, skills development of clinical operations team outsourced to Sponsor;
• Main Point of contact for Sponsor and link between Sponsor, KCR management team and clinical operations team;
• Recruit, interview and identify suitable candidates;
• Ensure and oversee proper onboarding and offboarding of employees (including hand-over activities), compliance to initial and ongoing training;
• Train and oversee the core competencies, ICH GCP knowledge and local regulations;
• Ensure direct reports provide timely and high-quality deliverables (KPIs compliance) and provide proper oversight on their productivity/ utilization;
• Perform Oversight Visits and review of Monitoring Visits Reports to assess CRA performance according to Oversight Plan and inform Sponsor of any quality concerns in timely manner;
• Conduct regular 1:1 meetings with direct reports to ensure deliverables and timelines;
• Ensure regular meetings with Sponsor to confirm the quality of service provided by assigned clinical country team; provide timely feedback to Sponsor and ensure proper follow-up;
• Communicate and escalate areas of development and training needs;
• Conduct continuous performance review and oversees personal development and career planning of direct reports;
• Perform other duties as assigned by Sponsor and/or KCR management team;
• Promote brand and enhance reputation of KCR.

Requirements:

• University degree from an U.S. Accredited School
• Relevant clinical research experience in a pharmaceutical company or CRO;
• Proficient with on-site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits);
• Minimum of six years relevant clinical research experience in a pharmaceutical company/CRO;
• Minimum of three years clinical experience in different therapeutic areas, including required experience in oncology;
• Thorough knowledge of drug development process;
• Thorough knowledge of relevant SOPs, ICH, and GCP guidelines;
• Relevant supervisory experience;
• Previous experience as a Line Manager
• Demonstrated ability to lead, motivate and to encourage team members to seek solutions;
• Proven interpersonal skills;
• Demonstrated ability to successfully manage multiple competing priorities under pressure of time;
• Open minded approach;
• Engagement in assigned tasks;
• Good communication skill;
• Strategic thinking skill;
• Advanced planning and organizational skills;
• Advanced oral, written and presentation skills;
• Computer competency;
• Fluent command of English;
• Available for travel up to 40% of the time, including overnight stays as necessary;
• Valid Driver's License;
• Valid Passport;

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 show that you are appreciated in our team, while working at KCR you will be provided with:

• 
  33 PTO days + 1 additional day off 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

• Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry

• Empowering workspace, with a flat hierarchy, offering opportunities to share ideas and influence company services development worldwide

• Possibility of getting involved in multinational studies

• Onboarding process to enable you fast takeover of duties and Buddy Mentor who will introduce you to the organization

• Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed

Please be informed that by sending application documents containing personal data to a wider extent than required by provisions of the labor law you are granting consent for the data to be processed by KCR S.A. with its registered office in Warsaw (6 Postępu St., 02-676 Warsaw) for the purposes of the ongoing recruitment.

If you want your candidacy to be considered also for future recruitments, please send us an additional consent: "I agree to the processing of my personal data for use in future recruitments conducted by KCR S.A. with headquarters in Warsaw for a period of up to 36 months". Such consent may be placed in a CV or electronic correspondence addressed to us.

You can withdraw your consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

More information on the processing of personal data can be found at: https://www.kcrcro.com/privacy-policy/