Head of Clinical Operations (m/f/d) - North America

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Job description

Location: home-based

Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives.

Optimapharm' s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.

With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators in all countries in Europe and North America. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.

We are looking for an ambitious Head of Clinical Operations, a strong, charismatic leader with a demonstrated knowledge of clinical trials delivery, to join our growing US team. If you are a dynamic, inspiring individual, come meet us! If you are an entrepreneur at heart and an intellectually curious person, talk to us!

What do we offer?

• Working in a successful company that's growing and developing every day
• Company that supports life balance
• Company with healthy culture
• Working with a highly experienced team of clinical research professionals
• Competitive salary
• Competitive PTO entitlement
• Health insurance, including vision and dental plans, to meet your and your family's needs
• Comprehensive pension plan to maximize savings and prepare confidently for the future
• Employee engagement programs
• Well-being initiatives
• Training and development program
• Fast-paced career path progression

Who are we looking for? Qualifications and Experience

• University degree in medical or life sciences (or an equivalent combination of education, training and experience)
• A minimum of 10+ years of clinical research experience is required (preferably within both, pharmaceutical and CRO environments)
• Excellent knowledge of GCP and ICH Guidelines required for clinical trial conduct, CTR and CTIS, ISO 14155, MEDDEV/MDCG guidelines concerning clinical investigations
• Must demonstrate a sound understanding of the drug development process and executing a project
• Excellent knowledge of regulatory requirements (international and local)
• Ability to interpret P&L and Balance Sheet
• Demonstrated ability to develop and carry out strategies, as well as provide operational excellence
• Entrepreneurial mindset and demonstrated ability to drive decision making and process improvement
• Strong leadership skills, ability to motivate and inspire a team while sustaining high levels of team engagement
• Excellent communication and management skills
• Ability to work in a fast-paced, team-oriented environment
• Computer proficiency is mandatory

Your responsibilities

• Work closely with the COO and the Company's Senior Management Team to ensure the Company's operational excellence within trials conducted in North America while developing operational strategies and capabilities aligned with overall company strategies.
• Capability to maintain a high level of satisfaction among existing clients and the ability to secure a new project awards
• Perform strategic planning, execution, and coordination of North American operations, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the company's strategy
• Leader with excellent management and communication skills, responsible for liaising with Senior Management within the Company to continuously assess and improve operational delivery; being responsible for people management and function management and accountable for project delivery
• Act as a mentor and be responsible for line management of assigned team members of the North American Operations
• Coordinate communication and collaboration between North American Operations and Head of Departments (PM, Clinical Operations, Regulatory and Start-up, Trial Support, DM, Biostatistical Services, Medical Affairs and Quality Assurance) and clients to ensure that project deliverables and requirements related to ethics, regulatory, patient safety and data integrity are met
• Promote new business by participating in the process of preparation of project bids, providing required inputs into Request for Information (RFI) and Request for Proposal (RFP), contribute to the development of budgets and proposals and for attendance of Client presentations/meetings (e.g. bid defense meetings) as appropriate and requested by Business Development Department (BDD) and/or senior management
• Support BDD and Commercial Operations Teams with expertise and consultation concerning Regulatory and Site Activation strategies

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

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