Director, Country Clinical Ops

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Director, Country Clinical Ops

Syneos Health

Home-based, Poland

Job responsibilities

STRATEGIC

Engages strategically and cross-functionally to step up country delivery and performance with, amongst others, Site Identification, Site Contracts, Site Payments, Site Activation Management, Site Relationships (Catalyst and SNP), Global Clinical Trial Management, Global Central Resourcing Management, Talent Acquisition, and Project Management;
Oversees country Book of Work to uphold project delivery reliability and efficiency, especially for, but not limited to, the achievement of deliverables on-time and on-quality;
Drives country clinical delivery to support and complement project financial performance, particularly as it relates to clinical operations’ services;
Ensures country service consistency, quality, efficacy, and effectiveness by bringing about a balanced and optimal team composition. This is inclusive of managing resources effectively in consideration of workforce planning, capacity, cross-resourcing opportunities, and productivity;
Acts as point of contact (POC) for country escalations coming from the clinical organization’s stakeholders (e.g., Project and Functional Leaders). Moreover, identifies risks and removes barriers to finding solutions to country delivery and performance challenges (e.g., at the site identification stage, for site activation progress, in setting up enrollment activities);
Consults with relevant parties to recommend and lead the implementation of inventive solutions in startup and monitoring delivery processes and as well, for study allocation needs and resourcing challenges;
Works in partnership with the Sites and Patients’ team, Project Delivery Leaders and, if applicable, the Regional General Management team, to identify study and patient population opportunities, strategic site relationship opportunities, and strategic country growth solutions.

LEADERSHIP

Demonstrates visible leadership of country team and across organizational collaborations;
Brings about commitment and accountability to country, project, and business performance in decision-making, and communicating to country team and collaborators;
Oversees and manages country financial performance to ensure departmental targets are met for, but not limited to, utilization, cost control (e.g., resource management), and revenue realization;
Establishes country team organization, RACI, and communication channels;
Fosters collaboration within Sites and Patients’ country and region and as well, across project and organization stakeholders (e.g., RWLP, FSP, FSO, therapeutic business units);
Reinforces Syneos Health’s culture of engagement and enables the implementation of country key drivers of employee engagement;
Advances country talent optimization especially with regards to identifying and making visible growth pathways and opportunities for team members. This is also inclusive of supporting the management of employees through goal setting enhancing skill levels and knowledge, the delegation of tasks commensurate with skill level, professional development, and performance management;
Fosters awareness and visibility of Syneos Health culture and heightens industry presence within country.

SUBJECT MATTER EXPERTISE

Acts as country operations subject matter expert (SME) by demonstrating knowledge of country operational processes, regulatory operations, and industry clinical research environment. May use other in country SMEs for support (e.g., regulatory intelligence SMEs);
Consults and supports the Proposal/Business Development teams to facilitate new project awards during the Pre-Award and Bid-Defense process and, where required, provides expert clinical operations guidance. May participate in marketing activities, client presentations, and proposal development;
Serves as sponsor country affiliate POC;
Establishes Key Opinion Leader (KOL) and Regulatory Authority relationships;
Engages with applicable industry network (e.g., CRO consortium, regulatory);
May serve as an office location site head and/or as office administrator for country legal entity.

Qualifications

What we’re looking for

Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including sometime in a leadership capacity or equivalent combination of education, training, and experience are required;
Extensive knowledge of and experience with GCP/ICH guidelines and other applicable regulations and/or regulatory requirements;
Demonstrated strong strategic, leadership, and tactical skills;
Knowledge of financial concepts related to forecasting, budgeting, proposal generation, and project budgeting;
Strong time management, technical and organizational skills and, the ability to work independently and within a team environment;
Demonstrated ability to self-direct tasks and set direction and priorities for others to achieve departmental goals;
Capacity to understand, communicate, explain, and put into detailed plans project concepts;
Demonstrated understanding of the workflow process, roles, and responsibilities of multiple functional areas;
Ability to anticipate and address critical issues and as well, develop contingency plans in an initiative-taking manner;
Must demonstrate proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to gain working knowledge in other applicable business tools and systems;
Requires above average diligence, accuracy, and organizational, interpersonal, change management and collaborative skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade. As well, requires the ability to hold challenging conversations and to engage across, amongst others, Project Delivery, Segment Lead, Sponsor and Functional Leaders;
Ability to travel as necessary (approximately 20%).