Date: 12 Jul 2023
$ads={1}
Location: DE
Company: AdvanzPharma
Job Title:
Clinical Research Manager
Location: Germany, UK, Spain
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.
Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.
ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
About the Role
As Clinical Research Manager the main objective of your role is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers – both internal and external - and generating and communicating relevant, meaningful and impactful data. In doing so, the Medical Office: represents the voice of the patient in all matters; works to ensure that products are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements.
As Clinical Research Manager you will be responsible for all operational aspects, managing the direction, planning, execution and data of clinical studies with a focus on post marketing, Phase IV, Real World Evidence, Patient Outcomes and Investigator Initiated Studies. He/she also identifies, partners with and oversees clinical research/clinical development organization (CRO/CDO), partner development activities and support clinical development due diligence activities.
What You’ll Do:
- Clinical study management scope includes mainly late phase research (Phase 3, Phase 4, Post Marketing) but involvement in early phase clinical development (pre-clinical, Phase 1 patient / health volunteer studies / Bioequivalence studies) may be expected.
- Responsible for selection and management of CROs and vendors for outsourced clinical study activities including monitoring, data management, statistics, etc.
- Creates clinical study budget and manages budget including verification of invoices associated with outsourced activities
- Oversees the implementation of all activities related to assigned clinical studies.
- Responsible of developing and ensuring high quality documentation throughout the clinical study.
- Works with all relevant groups including statisticians, bioanalytical team, clinical research scientists, data management, and medical monitors to ensure all activities are managed appropriately.
- Monitors, manages and reports clinical study timelines and provides progress reports to management.
- Conducts site feasibility assessments, site initiation visits, interim monitoring visits and close-out visits as required.
- Oversee the preparation of clinical study reports and related manuscript publication
- Assists with the review and QC of study documents, clinical study data and reports.
- Support conduct of GCP audit and inspection preparation of CROs, vendors, partners and investigational sites as required
- Ensure robust scientific and operational oversight of ongoing/new investigator-initiated research activity; participates in and coordinate ADVANZ PHARMA Study Board review meetings and ensures project management within agreed timelines.
- Support the preparation of regulatory briefing documents and clinical elements of regulatory submission documents for Health Agencies.
- Support the development of adequate standards & procedures for the effective planning, tracking, execution and reporting of clinical development and post marketing research activities.
- Identifies and escalates, where necessary, instances of non-compliance, company risk or exposure, or safety risks to study participants. Collaborate to process improvements and ensure compliance with ADVANZ PHARMA requirements. Ensures that ADVANZ PHARMA operates to partner requirements, where necessary.
- Ensures Good Clinical Practice (GCP) audit/inspection readiness.
- Provides functional metrics aimed at maximizing functional performance and efficiency, and reporting tools aligning performance against corporate business needs.
- Other tasks, as directed by the supervisor, or based on specific appointment, or determined during the annual objectives setting process, or by relevant key performance indicators
- Thrive in an entrepreneurial environment and take accountability for results.
- Embrace challenge and change, applying a growth mindset approach.
- Have a bias for action and fast decision making.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation.
- Contribute to making ADVANZ PHARMA a desired place to work.
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.
For this role, you will also have the following:
Qualifications:
- M.Sc. in a scientific discipline or a health-related background
Knowledge, Skills & Experience:
- 3-5 years relevant clinical research experience overseeing Phase III/Phase IV studies
- Experience in early phase clinical development (Phase I patient / health volunteer studies / Bioequivalence studies)
- Expertise in the generic, value added medicine and biosimilars areas, is a plus
- Good knowledge of EMA and FDA Clinical Study Regulatory Framework
- Expertise in endocrinology, infectious disease, hepatology or critical care therapy areas and research activities
- An expert understanding of the clinical research process from design to reporting
- Strong oral and written communication skills and interpersonal skills
- Strong collaboration & team skills with a variety of different cross-functional areas
- Excellent time management and work organization skills
- Fluent in English both written and spoken
- Self-driven; motivated, high energy, positive and dynamic individual with excellent planning, communication and cross functional collaboration
- Collaborative, team-oriented approach, and adept at developing and supporting relationships; an active contributor to cross-functional teams
- Ability to anticipate and plan for the future and see the bigger picture; able to focus on detail when required; works to ensure study subject safety at all times; critical thinker; able to identify problems and propose solutions
- High Integrity in business and people matters; trustworthy; strong compliance and quality mind-set.
- Ability to have fun!
- A positive and ‘can-do’ approach, biased towards finding solutions and embracing change
- Inspired by our values of entrepreneurship, speed and integrity
- Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows
- Work collaboratively across all business functions with an open, honest, and respectful cooperation
Why ADVANZ PHARMA?
The success of any company is driven by its people, and we are no different.
At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.
Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.
As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities and make things happen.
But there’s more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women’s Network; almost 40% of our managers are women.
We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.
We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.
To join us on our exciting journey, Apply now! *
- Please include a CV and Cover letter.
$ads={2}
