• Interesting projects, career advancement, and recognition and exposure to our international footprint;
• Flexible working conditions - Opportunity to work from home and flexible working hours;
• Competitive employee benefits;
• Annual Merit increases;
• Fast PACE® - Accelerated, tailored training program training program based on your experience;
• Opportunity for cross-functional and CRA leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager;
• Sign on bonus may be appropriate for qualifying candidates.

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• Must have a minimum of a university degree in a health or life science related field;
• 1.5 years’ work experience as a CRA;
• Oncology monitoring experience would be an advantage;
• Willing to travel approximately 60-80% nationally;
• Familiarity with Microsoft® Office;
• Must be detail-oriented and efficient in time management;
• Strong communication and presentation skills a plus;
• Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.
• Excellent verbal - written communication skills and excellent negotiations skills in Spanish and English.
• Excellent time management and organization skills.
  

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

• Benefits relevant to your country of residence. Usually this includes, at minimum, a car allowance, an annual performance-related bonus of up to 15%, and either medical coverage or a contribution towards this
• An opportunity to make an impact from day one in a team with huge aspirations and who are at the forefront of breakthrough medicine and science
• Hands-on learning, tailored to your needs and expertise, with the opportunity to grow and develop your career at your pace
• Remote working with flexible working hours (we’re outputs focused rather than hours focused), to enable you to ensure a great work life balance
• The opportunity to be part of something bigger with the advantage of our global presence
• A diverse, equitable and inclusive environment where every voice is heard. Our IDEA motto is “be true, be you” and we strive to ensure everyone feels a sense of belonging and can bring their true, authentic and best self to work
• An environment that empowers and supports colleagues to manage all aspects of their wellbeing by focusing on a holistic approach

• Collaborates in design of clinical study including methodology, data analysis & interpretation, and reporting of study results.
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents with minimum supervision
• Performs and/or validates statistical analyses, advise ways to maximize clarity of data display
• Communicates results to cross-functional teams, provides data interpretation in study documents such as clinical study reports, and publications.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
• Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
• Continually enhances knowledge of drug development process, regulatory and commercial requirement
• Develops & advises team members.
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.

• Fresh PhD with 3+ years' experience or MS with 5+ years' experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
• Good interpersonal, communication, writing and organizational skills
• Ability to:

• Experience in standard and advanced statistical methods is preferred.
• Good understanding of regulatory requirements & clinical trial design is preferred.

RESPONSIBILITIES

· Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).

· Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.

· Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal l products.

· Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.

· Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.

· Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.

· Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.

· Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

· Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.

·  Around 4 years relevant clinical experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.

·  Resident in Poland with fluent Polish language skills (at least C2).

·  Excellent command of the English language.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

· In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.

· Excellent knowledge of the pharmacovigilance legal framework in Poland.

· Solid knowledge of relevant Standard Operating Procedures (SOPs).

· Possess excellent written and verbal communication skills.

· Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections.

· Strong organizational and project management skills

· Ability to establish and maintain effective working relationships with coworkers, managers, customers and third parties

· Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product

· Demonstrate an understanding of compliance and of quality management systems

PHYSICAL REQUIREMENTS

· Availability by phone 24/7 for Competent Authority enquiries.

· Resident in Poland.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Apply Here

• Ensure protocol compliance
• Supports review by a duly constituted IRB
• Manage the medical care of subjects
• Protect the rights and welfare of subjects
• Ensure the validity of the data reported to sponsors
• Ensure documentation of study-related procedures, processes, and events
• Ensure the proper use and storage of investigational agents
• Support site operations

• Minimum of 2 years’ experience in performing physicals, assessing, and treating patients.
• Strong supervision, interpersonal and communication skills.
• Must possess exceptional organizational and planning skills and good documentation skills.
• Must have good conflict resolution skills and be committed to quality.
• Must be punctual and have a flexible work schedule to include on call, weekends and holidays if needed
• At least 2 years’ experience in clinical research as an investigator or sub-Investigator.
• In-depth knowledge of the clinical research process, including Good Clinical Practices.

• Required: Medical (M.D.) degree with at least 2 years of clinical research experience.
• Preferred: Medical degree plus at least 5 years of clinical research experience with 2 years in Phase 1 research.

Senior Director, Study Start Up Head

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. 

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. 

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. 

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. 

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. 

The Opportunity:

As the Study Start Up Head (Senior Director) you will establish and lead the global study start-up department, ensuring delivery, resourcing, quality, and contractual compliance for all clinical development studies (ED & Late-Stage) across all regions.

In this role you will provide strong leadership and management to the study start-up team, addressing escalated / recurrent issues, finding resolutions, and continuously improving operational efficiencies of study start up activities. You will oversee and provide strategic direction for the global execution of study start up activities for all Clinical Development Studies (Early Development & Late Stage) which may include Site & Country Feasibility, Contract & Budget Negotiations, Site Payments, Regulatory Document Collection to support site initiation, ICF, site qualification & initiation visit coordination, and IRB / EC submissions.

This role reports to the Executive Vice President, Head of Clinical Operations, Data Sciences and China Development.

Responsibilities:

• Acting as the primary decision-maker for portfolio study start-up issues, collaborating with cross-functional teams to resolve problems at the study level. Monitoring portfolio performance against site activation timelines and metrics (e.g., as defined by corporate objectives), while adhering to budget targets
• Managing allocations of study start-up staff which includes regulatory document collection and site contracts/budgets, and frequently update resource algorithms based on portfolio needs
• Supporting identification of and executing interventional trial support strategies aimed at increasing productivity and quality while decreasing cycle times and cost and for the development and implementation of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development, along with other functions and across the early and late stage clinical organisations for the relevant support functions.
• Acting as a member of the Extended Clinical Operations Leadership Team (COLT) and providing input into sub-division structure, budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.

Essential Knowledge & Experience:

• Demonstrable expertise in clinical trials including extensive leadership experience of global study start-up activities and study delivery.
• Recognised leader in functional management and direct people management
• Proven track record of experience in working with teams to prepare for regulatory inspections including inspections readiness, participating in regulatory inspections and preparing responses to inspection findings.
• Strong knowledge of current regulations, trends and practices in areas of support function responsibility
• Must have demonstrated extensive expertise in developing global clinical development strategies along with strong knowledge of ICH/GCP guidelines including multinational clinical trial guidelines

Preferred Experience:

• Represented or participated as a member of governance committees both with vendors and external collaboration,
• Partnered with cross-functional leaders on initiatives, activities and deliverables that span across Clinical Operations
• Experienced in managing international employees.
• Management experience in multiple clinical operations positions
• Clinical trial management leadership

Education/Qualifications:

• Bachelor’s degree or equivalent.

Additional Information:

• This is a permanent, full-time position.
• This position is based in EU or US.
• This position is 100% home/remote based.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Apply Now

• Benefits relevant to your country of residence. Usually this includes, at minimum, a car allowance, an annual performance-related bonus of up to 15%, and either medical coverage or a contribution towards this
• An opportunity to make an impact from day one in a team with huge aspirations and who are at the forefront of breakthrough medicine and science
• Hands-on learning, tailored to your needs and expertise, with the opportunity to grow and develop your career at your pace
• Remote working with flexible working hours (we’re outputs focused rather than hours focused), to enable you to ensure a great work life balance
• The opportunity to be part of something bigger with the advantage of our global presence
• A diverse, equitable and inclusive environment where every voice is heard. Our IDEA motto is “be true, be you” and we strive to ensure everyone feels a sense of belonging and can bring their true, authentic and best self to work
• An environment that empowers and supports colleagues to manage all aspects of their wellbeing by focusing on a holistic approach

• This is a zero-hours contract offering flexible working hours .
• You´ll be available to work Monday to Friday, 9 am to 5 pm, with the potential to work up to 37 hours per week. However, you may not be guaranteed these hours every week as these will vary depending on business needs.

• GCSE education; ideally in science subjects.
• Administrative experience, gained at a general office setting, ideally in a Healthcare environment.
• Excellent telephone manners.
• Able to demonstrate working knowledge of Microsoft Office (Outlook, Word, Excel)
• Knowledge of medical terminology preferred.

• Receive GP Report Consent Forms from potential subjects and amend the Recruitment Participants database accordingly. Review GP Report Consent Forms for completeness, prior to sending to relevant GP
• Liaise with GPs and surgeries to expedite return of GP Reports and collate GP Reports for review.
• Record receipt of GP reports into databases, preparing the updates needed.
• Scan, quality check and file GP Reports as appropriate.
• Liaise between physicians and GPs to clarify queries.
• Notify the GPs of their patient's inclusion in studies.
• Enter medical history and demographic information from potential subjects into computerized database.
• Communicate study information to potential subjects.
• Use the mail merge facility on the recruitment database generate letters.
• Run multiple reports from database to generate spreadsheets, letters, texts and emails

• Develop and implement a comprehensive marketing strategy for promoting Cetaphil through physicians and healthcare providers.
  
• Establish relationships with key opinion leaders, medical societies, and other healthcare organizations to build brand awareness and generate leads.
  
• Work with cross-functional teams to create marketing materials, including brochures, presentations, and digital content, to support physician outreach and education initiatives.
  
• Plan and execute physician education and training programs to increase awareness and adoption of healthcare products and services.
  
• Analyze market trends and competitor activity to identify opportunities and develop strategies for differentiation.
  
• Develop and manage budgets for physician marketing initiatives, including events, digital marketing, and other promotional activities.
  
• Work with Regions and strategic markets General Managers and Business Units Heads to develop sales collateral and other materials that support the physician referral process.
  
• Monitor and report on the effectiveness of physician marketing initiatives, including metrics such as lead generation, conversion rates, and ROI.
  
• Collaborate with other departments, such as product development and customer service, to ensure alignment of marketing efforts with overall business objectives.
  
• Stay up-to-date with healthcare industry trends, regulatory changes, and best practices in physician marketing.
  

• Strong experience in consumer healthcare marketing, with a focus on physician referral marketing and relationship building. Dermatology experience strongly desired.
  
• Proven experience in developing and executing successful global marketing campaigns and initiatives.
  
• Demonstrated experience in building, transforming and growing rapidly business in strategic markets i.e. USA. China, Philippines, Canada, India, ANZ, Germany, Brazil .
  
• Strong leadership skills and ability to manage cross-functional teams and external partners.
  
• Excellent written and verbal communication skills, including the ability to present complex information to diverse audiences.
  
• Knowledge of healthcare industry trends, regulations, and best practices.
  
• Ability to analyse data and identify insights to inform marketing strategy.
  
• Experience with digital marketing and social media platforms.
  
• Ability to work in a fast-paced environment and manage multiple projects simultaneously.
  
• Creative problem solver with a strong customer focus. Performance driven .
  

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  
• You will receive a competitive compensation package with bonus structure and extended benefit package
  
• You will be able to work in a hybrid work culture
  
• You will participate in feedback Loops, during which a personalized career path will be established
  
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability
  

• Send your CV in English
  
• If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition
  
• The next step is a virtual conversation with the hiring manager
  
• The final step is a panel conversation with the extended team