Due to our continued growth Precision for Medicine is hiring an Associate Director, Site Start up to join our team, candidates can work remotely in UK, Spain, Poland, Serbia, Hungary, Romania or Slovakia.
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 SSU Executive Director 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 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 SSU leadership 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 SSU leadership 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
Ensures compliance with company policies and procedures and other applicable regulatory guidelines
- Supports coordination of SSU’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
- Contributes to the development, measurement and reporting of SSU KPIs and supports 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
Qualifications:
Minimum Required:
- Bachelors degree in life sciences or related field, or equivalent combination of education, training, and
experience.
- A minimum of 10 years in clinical research including extensive experience of Site Start-up working within a CRO environment
- Strong leadership experience or proven competencies for this position.
- Demonstrated knowledge of GCP/ICH guidelines and the clinical development process.
Other Required:
- Proven 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 demeanour
- Experience in managing clinical aspects of complex and global trials
- Proven experience in strategic planning, risk management and change management
- Fluency in English.
Preferred:
- Advanced degree in life sciences or related field
Competencies
- Ability to work closely with business unit leadership to understand customer's needs
- Strong analytical skills and business acumen
- Strong presence with ability to confidently deliver complex presentations to senior management or clients
- High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.
- Ability to lead and inspire excellence within a team
- Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
- Results oriented, accountable, motivated and flexible
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
- Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment
- Proven ability to effectively influence, negotiate, and manage conflict
- Proven financial management skills including project financial tracking
- Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
- Excellent presentation, verbal and written communications skills
- Proven experience in delegating while fostering cohesive team dynamics
- Occasional travel may be required.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.#LI-NC1 #LI-RemoteAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers.
We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
