Director, Site Start Up

Pfm; Deutschland; Remote; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Precision for Medicine in Germany seeks a Director, Site Start Up to lead the SSU department and shape the strategy for compliant trial start-up delivery. You will guide the SSU team, support regulatory submissions and site contracts, and collaborate with Clinical Operations and Global teams to ensure flawless start-up across regions.

The role requires extensive leadership, deep GCP/ICH knowledge and a track record of strategic planning, risk management and change management to propel PfM’s

Qualifikationen

• Bachelor's degree in life sciences or related field, or equivalent experience.
• Minimum 12 years in clinical research with extensive site start-up experience.
• Expert knowledge of GCP/ICH guidelines and the clinical development process.
• Fluent English and strong leadership in a matrix, global environment.

Aufgaben

• Provide SSU team guidance, leadership and support for project delivery.
• Oversee regulatory submissions (IRB/EC, CA) and site contracts/budgets.
• Collaborate with Clinical Operations, PM and cross-functional teams globally.
• Develop SSU framework, KPIs and drive continuous improvement.

Kenntnisse

Leadership

Regulatory knowledge

Project management

Communication

Ausbildung

Bachelor's degree in life sciences

Tools

MS Office

CTMS

eTMF

EDC

Jobbeschreibung

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Due to our continued growth we are seeking a Director, Site Start Up

Position Summary:

Provides leadership to the Site Start-up (SSU) department. Contributes to the strategy and direction of the implementation and expansion of the SSU department in terms of people, processes and systems. Collaborates with other functions to secure SSU delivery and client satisfaction on SSU activities (typically, these include activities such as Informed Consent Form review and adaptation, Regulatory Document collection and quality review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group in budget and contract negotiation). Works closely with the Head of Site Start Up on the ongoing development of SSU . Ensures the conduct and delivery of clinical trials in compliance with Regulatory requirements (local and regional), ICH Guidelines, Good Clinical Practices (ICH) and SOPs.

Essential functions of the job include but are not limited to:

• Provides SSU team with guidance, leadership and overall support relating to SSU project delivery, communication, human resources, revenue enhancement, procedures, systems and processes to meet client and departmental targets.
• Supports the overall management of site start up delivery either by direct management and/or cross functional oversight of the depts involved in the different areas of site start-up (Local/Central IRB/Ethics Committee (EC) submissions, Competent Authorities (CA) submissions, other related governing organizations/bodies, site contracts and budget negotiations and any other start up requirements).
• Works closely with the Head of Site Start Up to establish the Precision for Medicine (PFM) SSU framework to ensure project execution and delivery including SSU intelligence, tools and methodology, risk evaluations and mitigations.
• Supports SSU collaboration with Clinical Operations team, project management and other relevant cross functional departments in the planning, execution and governance of SSU activities globally and/or regionally
• Works with the Head of Site Start Up to support defined corporate and departmental business strategies for PfM
• Acts as an ambassador for change management for evolution of global structure for PFM growth and expansion
• Provide leadership and oversight on SSU programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design)
• Manage escalations and remediation of SSU concerns timely and effectively
• Supports optimization of processes and delivery with the goal of contributing to the profitability of the SSU teams to meet or exceed budget targets
• Partner with Global Resourcing teams for assessment and management of team members (SSU leads, SSU Specialist and Site Contract Management staff) to ensure that established cost, time, and quality goals are met
• Supports SSU team career development, growth and succession planning activities. Ensures compliance with company policies and procedures and other applicable regulatory guidelines
• Supports coordination of SSU Lead’s participation in current and prospective client meetings and presentations to ensure PfM customer service is well represented
• Collaborates with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance for any SSU participants
• Works with global/regional functional leaders to support SSU project strategy and SSU delivery
• Supports SSU evaluations and implements required changes for all projects
• Develop, measure and report SSU KPIs and lead continuous improvement
• Recognize, exemplify, and adhere to PFM’s values that center on our commitment to quality, our people, clients and performance
• Leverage communication skills and experience to reinforce PfM culture and values to motivate, maintain engagement and drive retention for SSU team

Requirement :

• Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience.
• A minimum of 12 years in clinical research including extensive experience of Site Start-up
• Extensive leadership experience or proven competencies for this position.
• Expert knowledge of GCP/ICH guidelines and the clinical development process.

Other Required:

• Demonstrated leadership track record
• Experience working in team environment with resource management experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Proven experience in strategic planning, risk management and change management
• Fluency in English.

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