Start-up Associate Manager/COM-R

Start-up Associate Manager/COM-R

Remote - USA

Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

We are seeking a Clinical Operations Manager - Regulatory to Lead start-up team during study start-up phase liaising directly with Lead Start Up Project Manager or Project Lead, core team members and the client, as applicable.

In this role, the selected candidate will serve as client's contact for start-up and maintenance processes and oversight; be responsible for establishing a strong working relationship with client's project teams; monitor and control start up project schedule and scope; proactively engage in both quality assurance and risk management activities to ensure project deliverables are met; and initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects.

Responsibilities include:

• Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Development of local language materials including local language Informed Consents and translations.
• Collaborate with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
• Oversee country and site budgets.
• Partner with local clinical team/s to successfully deliver clinical and financial contracts within fair market value.
• Manage and track clinical research-related payments - Payment reconciliation at study close-out.
• Ensure country deliverables, timelines and results for assigned protocols are met to meet country commitments.
• Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
• Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
• Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.

Education

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• In lieu of the above requirement, candidates with minimum of 5 -7 years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries (IRB/IEC etc.)
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal

Experience

• Good organizational and time management skills
• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
• Excellent communication skills, oral and written.
• Self-motivation with the ability to work under pressure to meet deadlines.
• Works well independently as well as in team environment.
• Detail and process oriented
• Positive attitude and approach
• Interact with internal and external customers with high degree of professionalism and discretion.
• Multi-tasking capability.
• Ability to lead and develop junior staff.
• Flexible and adaptable to a developing work environment

Pay Range: 90-120K

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.

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