Alvotech is a privately owned, fully integrated specialty biopharmaceutical company focused exclusively on the development and manufacturing of high-quality biosimilar products, all along the value chain from cell line development to commercial manufacturing. The company is well on its way to becoming a global leader in the biosimilar space and is helmed by an outstanding management team and prestigious group of shareholders.
Alvotech prides itself on attracting highly experienced industry talent, drawn by its purpose-driven culture. With its strong emphasis on excellence and commitment to improving the lives of patients by making biologics more accessible around the globe, Alvotech strives to promote a culture of diversity and inclusion.
See more at Alvotech.com
The Clinical Data Manager will be responsible for oversight of all clinical data management activities in support of the Alvotech’s pipeline. This includes, but is not limited to, execution and ownership of the Clinical Data Management (CDM) operating model; leadership in technical innovation related to CDM; and engagement with peers within the Clinical and Medical Affairs Organisation
The Clinical Data Manager will report to and will be supervised by the VP Clinical Operations, within the Late Stage Research and Development Department.
Within his/her function, the Clinical Data Manager is responsible for oversight and interaction with all CRO partners to ensure adherence to tasks in accordance to development program timelines, performing the required activities on budget, and with the highest standard of quality.In addition, the Clinical Data Manager is responsible to ensure that high quality systems are used in collaboration with CRO partners, and that processes and procedures are in alignment with Good Clinical Practice (GCP) and Good Clinical Data Management Practices (GCDMP).As part of a multifunctional team, the Clinical Data Manager will be responsible to collaborate with cross-functional individuals (e.g. Clinical Operations, Clinical Science, Medical Affairs, Safety/Pharmacovigilance, Regulatory Affairs, Project Management, Clinical Supplies) in support of project deliverables. Therefore, the Clinical Data Manager should be able to work independently as well as feel comfortable in working within a multifunctional team. As a consequence, both self organizational, leadesrship and interpersonal skills are required for this role.For this role, long-standing exprience in all phases of clinical drug development and a thorough understanding of the overall drug development process as well as a strong operational background, is required.A proven track record of effective matrix management is required as well as high level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills are expected.Good knowledge and understanding of Data Management systems, GCP and GCDMP is an essential requirement for this role, as well as very good understanding of operational aspects associated with the conduct of a clinical program.The primary location for this role is Alvotech‘s office in Zurich. It is expected that
Clinical Data Manager will have to travel internationally, as required by the Project related or Department activities.
- Examples of main responsibilities for a Clinical Data Manager are to:
- Oversee the use of high quality systems in partnership with CROs, estblishing processes and procedures in alignment with GCP and GCDMP in order to provide data of excellent quality to support decision making.
- Oversee data management portions of clinical trial budgets and CRO data management staff.
- Support and contribute to CDM strategy and collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Medical Affairs, Safety/Pharmacovigilance, Regulatory Affairs, Project Management, and Clinical Supplies in support of project deliverables and regulatory needs.
- Manage outsourcing providers and preferred partnerships and collaboration activities for CDM including proper oversight activities, performance metrics, continuous improvement, and established alliance governance.
- Oversee the strategy of technology platforms related to Electronic Data Capture (EDC), data visualization, programming, and risk based monitoring.
- Deliver high quality EDC databases, ensure flawless execution during clinical trial conduct, and provide the clinical team with analysis ready and reliable data after database lock.
- Overview the development, maintenance and governance of CDM standards (custom eCRF, CDASH etc.).
- Establish reports to assist with data cleaning, query metrics, and identification of data trends.
- Participate in the development of EDC custom report specifications as needed.
- Be responsible to implement and update / improve policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs), as required.
Key Responsibilities and Work assignments
Typical responsibilities and work assignments are to:
- Perform thorough reviews of critical CDM documentation such as electronic Case Report Form (eCRF) specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.
- Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
- Review data transfers for consistency with available specifications, e.g. annotated CRFs, SDTM specifications.
- Participate in trial document reviews, e.g. clinical trial protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
- Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document.
- Participate to the clinical and pharmacovigilance databases reconciliation.
- Participate in data blind review prior to final database locks.
- Keep training records up-to-date.
Language Skills: Fluent in English, both written and verbal. Any additional language is a “nice to have“.
- Computer Literacy: Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint in addition to technical software required for the specific function.
- Organization and Management Skills: Required to lead, participate and make positive contribution to team meetings.
- GCP Experience: Deep knowlege and understanding of GCP and GCDMP. Will participate in internal and external audits as well as regulatory inspections.
- Collaboration and Interpersonal Skills: Expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowlege and experience with other team member.
Competencies required to fulfill the employee responsibilities and work assignments:
- An employee shall follow the job description that pertains to his/her position. In addition an employee shall follow the SOPs that pertains to his/her position.
- An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
- It is important that an employee has the company values at heart in his/her work.
- An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
- Additional competencies required to fulfill key management responsibilities:
- Managers are always responsible for following the procedures that the company has established regarding environmental, health and safety issues.
- Manager is responsible for the conscientious and efficient operation of his department and the training of his staff.
- He is under obligation to follow developments in comparable fields and to seek solutions that boost the performance of his workforce and decrease the company’s overall costs.
- Education: (Minimum)
- Master of Sciences or equivalent:
- 10+ years in relevant functions in the Pharmaceutical Industry, or equivalent with at least 5 years in a Data Management Leadership role.
- Proven Leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment required.
- Deep subject matter expertise in Clinical Data Management and associated technologies and processes.
- Extensive knowledge of GCP, GCDMP and other relevant ICH/regulatory guidelines.
- Demonstrated experience leading and/or building a Clinical Data Management group and/or function.
- Experience with successful oversight of vendor/strategic partner relationships, including significant outsourced operations, and proven track record of ensuring quality deliverables or services in a cost-effective manner.
- Willingness to travel domestically and overseas, if required.
- Alvotech is a multinational workplace with employees from all over the world, benefitting from the diversity and the great talent that all of the employees bring into their work.
- Alvotech is a dynamic company that is expanding and growing at a fast pace which involves a lot of growth opportunities for employees within the company.
- Alvotech‘s working environment is friendly and full of energy, employees maintain their good energy by enjoying gourmet bistro at lunchtime; a professional coffee bar and a fully equipped gym with classes thaught daily.
- Alvotech has an active social life that is highly appreciated by the employees, managed by a group of employees that plan all kinds of fun events.
- Alvotech is committed to being at the cutting edge of technology by using some of the best equipment and processes in the industry. With the core mission of improving people´s lives by providing live changing treatments to patients worldwide, the purpose of all Alvotech employee´s work is clear.
- Alvotech already has a powerful group of people that are experts in their fields and we are excited to have more great colleagues to join us.
It is requested that the applicant is able to start work at the earliest possible convenience. All applications will be handled as confidential.