About Johnson & Johnson – Janssen
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in the Nordics are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.
Janssen, one of the Pharmaceutical Companies of J&J, with more than 35,000 employees working hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time – from autoimmune diseases, hematology, oncology, HIV, mental disorders, heart disease and diabetes. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring together ground-breaking science and the most creative minds in the industry to think differently about how diseases are treated and prevented. We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health. We are Janssen. We collaborate with the world for the health of everyone in it.
Introduction
Janssen is now looking for a Local Clinical Operations Manager (LCOM) in Finland that serves as the primary contact at a country level for assigned trials via all Therapeutic Areas. Identifying, and managing connections with external partners of high-performing sites, as well as communicating between key stakeholders from internal Janssen and external partners, are a basic delivery. The position will be office based in Helsinki, Finland.
Local Clinical Operations Manager - Finland
The LCOM is responsible for supporting the allocated trial teams to deliver quality data and trial documents/records compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The focus is on utilizing and gaining expertise in Feasibility processes and managing potential site issues that could affect multiple trials. Responsibilities may include assisting with and conducting site identification, selection, pre-trial assessment, initiation, as-needed support on-site contracting, as well as subject recruitment and retention and monitoring activities throughout the trials.
The LCOM role actively leads or contributes to process improvement that raises awareness of Janssen Finnish Clinical trials. Ultimately, the LCOM supports internally and externally the growth of the volume of Janssen Clinical trials in Finland.
Objectives of the Position
- Acts as primary local clinical operations contact for assigned trials in Finland. May represent GCO on cross-functional teams. Ensures local regulatory and GCP relevant intelligence is up to date to support allocated study teams and central functions to achieve successful HA/EC submissions.
- Collaborates with Functional Manager (FM)/Clinical Research Manager (CRM) in conjunction with allocated study teams consisting, e.g., of CTA, SM and CTM/GTL on country outreach and site feasibility assessment to select a final site list. Implements any local criteria for site selection.
- Implements and/or influences local regulations or practices impacting clinical operations in close collaboration with local pharma industry association as needed.
- Responsible for executing activities within site start-up and initiation period and during conduct of site monitoring/management in order to speed up the process and activate sites in shortest possible timeframe in accordance with external regulations SOPs, Work Instructions (WIs) and policies.
- Helps to drive site contracting processes with relevant internal and external stakeholders.
- May participate in site feasibility and/or pre-trial site assessment visits. May conduct accompanied site visits with SMs as delegated by FM.
- May attend/participate in investigator meetings as needed.
- Supervises country progress. Leads and coordinates previously aligned local trial activities and project planning activities to deliver high quality data on time and within study budget. Develops and installs contingency plans in a proactive way and drives issue resolution in a timely manner.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Establishes and maintains excellent working relationships with external partners, like site staff and sites’ administrative departments and internal partners, including but not limited to Medical, Patient, Regulatory Affairs.
- May submit requests for vendor services and may support vendor selection. LD Version 0.2 dated 21 April 2023 Specialist 4, Clinical Trial Admin/Oper (PG 26) DRAFT
- Complies with relevant training requirements.
- May support local Management Review in collaboration with local Commercial Quality partners. 14. Contribute and encourages process improvement, training and mentoring of CTAs, SM and LTMs in country-specific topics. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.
- Contributes input to the study management documents at a country level, if needed
- Prepares country-specific informed consent in accordance with procedural documents/templates. Reviews and manages site-specific informed consent forms by SOPs, other procedural documents and applicable regulations.
- If applicable, organize and ensure IEC/HA approvals and ensure that the trial complies with local regulatory requirements. Principal Relationships: Primary Reporting Structure: Reports to a Functional Manager/CRM Primary interfaces: Functional Manager/CRM, LTMs, SMs, CTAs and CTMs/GTLs Other Internal Interfaces: R&D Country Head, Compliance Manager/Specialist, Local Safety Officer Contract and Centralized Services, R&D study team (e.g., SRP), Medical Country Director and delegates (MAF) External Interfaces: Investigators, trial site personnel and administrative delegates at site, external vendor representatives (e.g., CRO), Ethics Committee, Health Authorities, local EFPIA organization (local pharma industry association) and others as required.
Qualifications
- Degree in a relevant scientific (life sciences) discipline.
- Graduate degree (Master’s or Doctorate) in a relevant Clinical Operations field such as pharmacy, health sciences
- Minimum of four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience). However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Should have a solid understanding of the drug development process, including GCP and local regulatory requirements.
Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills and solid computer skills are required.
What you will need to succeed
- Strong leadership and networking skills
- Ability to work in a cross-border setting
Ability to motivate professional colleagues and stakeholders. Conflict resolution/management and negotiation skills.
- Demonstrate ability to lead initiative/small teams.
- Flexible mindset and ability to work in a fast-changing environment.
- Willingness to travel with occasional/regular overnight stay away from home, depending on the region.
- Ability to work on multiple trials and Therapeutic Areas in parallel in different disease areas, if required.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Application
If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the 7-days posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
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