Director, Site Start up
reputed company is hiring a Director, Site Start up to join reputed company. We can consider candidates working remotely in the UK, Spain, Poland, Hungary, Serbia, Slovakia or Romania.
Position reputed company:
Provides leadership to the Site Start-up (SSU) department. Contributes to the reputed company 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 reputed company satisfaction on SSU activities (typically, these include activities such as Informed Consent reputed company review and reputed company, Regulatory Document collection and reputed company review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site reputed company 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 reputed company 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, reputed company, reputed company enhancement, procedures, systems and processes to meet reputed company and departmental targets.
- Supports the overall management of site start up delivery either by reputed company management and/or cross functional reputed company of the depts involved in the different areas of site start-up (Local/Central IRB/Ethics Committee (EC) submissions, Competent Authorities (CA) submissions, other reputed company governing organizations/bodies, site reputed company and budget negotiations and any other start up requirements).
- Works closely with the Head of Site Start Up to establish the reputed company (PFM) SSU reputed company 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 reputed company of global structure for PFM reputed company and expansion
- reputed company leadership and reputed company on SSU programs including large programs or programs that are increasingly reputed company (in scope, reputed company contribution, volume and design)
- Manage escalations and remediation of SSU concerns reputed company and effectively
- Supports optimization of processes and delivery with the goal of contributing to the profitability of the SSU teams to meet or reputed company 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 reputed company goals are met
- Supports SSU team career development, reputed company and succession planning activities. Ensures compliance with company policies and procedures and other applicable regulatory guidelines
- Supports coordination of SSU reputed company’s participation in reputed company and prospective reputed company meetings and presentations to ensure PfM customer service is reputed company 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 reputed company and SSU delivery
- Supports SSU evaluations and implements required changes for reputed company reputed company
- reputed company, measure and report SSU KPIs and reputed company reputed company improvement
- Recognize, exemplify, and adhere to PFM’s values that center on our commitment to reputed company, our people, clients and performance
- reputed company communication skills and experience to reinforce PfM culture and values to motivate, maintain engagement and reputed company retention for SSU team
Job Qualifications:
- Bachelors degree in life sciences or reputed company field or equivalent combination of education, training, and experience.
- A minimum of 12 years in clinical research including extensive experience of Site Start-up
- Experience working for a Clinical Research Organisation (CRO)
- Experience in people management
- Expert knowledge of GCP/ICH guidelines and the clinical development process.
- Demonstrated leadership reputed company record
- Experience working in team environment with resource management experience
- Experience with reputed company Office Products (reputed company, Word, reputed company, PowerPoint) and clinical software experience (CTMS, eTMF, reputed company etc)
- Excellent communication and interpersonal skills to effectively reputed company with others in reputed company setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Proven experience in strategic planning, risk management and change management
- reputed company in English.
reputed company is the first global precision medicine clinical research services organization, purpose-reputed company to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations reputed company, with laboratory expertise, and advanced data sciences to inform every reputed company. We apply our expertise to trials at reputed company stages—from early development through approval—with embedded experience in oncology and rare disease.
Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice.
reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law.
If 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 reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at .
Recruitment Fraud Warning: Please be reputed company that fraudulent individuals and websites may impersonate reputed company or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. reputed company will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you reputed company you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at so we can investigate and take appropriate reputed company.
Originally posted on Himalayas
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