Clinical Trials Program Manager
12-month contract
On-site – Dublin City
Hourly rate
39 hour week.

Here at Hays Specialist Recruitment we are currently supporting a multinational biopharmaceutical company that researches and develops treatments for various diseases.
They are currently seeking to hire a Clinical Trials Program Manager for a minimum of 12-month contract.

You will oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will be responsible for the resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce.

You will participate and engage in Clinical Operations and/or cross-functional organisational change initiatives. You may act as the business process owner (BPO) and/or serve as a subject-matter expert for Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardisation across Clinical Operations.

RESPONSIBILITIES:
• Provides ongoing financial oversight of clinical trials/programs assigned.
• May provide input into strategic and operational short and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
• Provides guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
• Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
• Partners with cross-functional teams to manage, adjust and revise project timelines and budgets as needed.
• Communicates project status and issues and ensures project team goals are met in alignment with project decisions. Escalates issues as needed.
• Participates in the development of all study-related documentation, including study protocols.
• Participates in the selection, management and oversight of contract research organisations (CROs) / vendors, including development of requests for proposals (RFPs).
• Anticipates obstacles and difficulties and implements solutions to achieve project goals, including risk assessment and mitigation strategies.
• Resolves issues as needed within national and international regulations and guidelines.
• Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
• Participates in and/or leads departmental or interdepartmental strategic initiatives.
• As assigned, initiates, authors, or otherwise contributes to standard operating procedure (SOP) development, implementation, and training.
• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
• Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
• People Leader Path: Hires, develops, and retains diverse top talent in the team. Sets clear expectations for direct reports, and coaches direct reports on their performance, development and career interests.

Minimum Education & Experience
• BA / BS / RN with 8 or more years’ relevant clinical or related experience in life sciences or MA / MS / PharmD / PhD with 6 or more years’ relevant clinical or related experience in life sciences.
• Minimum of 4 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study or project teams.
• Experience developing RFPs and selection and oversight/management of CROs or other vendors.
• Proven ability to successfully start up, manage and close-out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
• Meets all requirements for a Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable proficiency.

Knowledge & Other Requirements
• Advanced knowledge of one or more disease or therapeutic areas, as evidenced by independence in designing, implementing, and managing study team plans, deliverables and resource management.
• Complete knowledge of full cycle study management, from start-up to close-out.
• Advanced knowledge of study management best practices and tools and has shown the ability to apply these to improve study efficiencies and effectiveness.
• Thorough knowledge of the Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
• Proven ability to effectively author clinical study and regulatory documentation.
• Ability to lead and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.
• Demonstrated effectiveness by coaching, guiding and directing the work of others, effectively managing the performance of others, and developing team capabilities.
• Demonstrated effectiveness in proactively managing change.
• Strong communication and organisational skills.
• As required, the ability to travel