Global Clinical Operations Manager

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets.
For one of its subsidiaries, Janssen - a company dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases, Johnson & Johnson is looking to hire:

GLOBAL CLINICAL OPERATIONS MANAGER
Region: Sofia, Bulgaria
Full-time unlimited contract

Role Overview
The Global Clinical Operations (GCO) Manager has a dual role Functional Manager (FM) and Quality & Compliance Specialist (Q&CS).
The position is accountable for the successful regional or country execution of all phases of clinical trials for an assigned Therapeutic Area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with all GCO SOPs, policies and regulatory requirements. This position is responsible for the direct functional management of Local Trial Managers, Site Managers and Investigator Document Associates/Clinical Trial Assistants and other TCSM functions, where applicable.
The position is also responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality compliance approach for clinical trials in close collaboration with local and global quality functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.

Functional Management responsibilities:
• Evaluates and projects resource needs for assigned portfolio, and liaises with local TCSM management for resource requests as appropriate.
• Strong interaction with Flex Resource managers to provide feedback on Flex Resource performance. Works with Flex Resource managers to on-board and off-board staff
• Interviews, hires, develops and trains staff. Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
• Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance in Learning @ Pharma R&D
• Ensures adequate, timely and compliant management of clinical studies through all phases of the trial- feasibility through database lock
• Ensures studies are in a constant state of inspection-readiness. Works with Quality Management (QM) liaisons to ensure quality oversight of studies utilizing the available tools.
• Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO
• Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation
• Communicates with staff on program changes, policy changes and priority shifts
• Conducts Accompanied Site Visits with Site Managers

Quality Oversight Activities:
• Monitor compliance risk and ensure mitigation/remediation actions are defined
• Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations
• Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
• Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
• Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.
• Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
• Provide advice regarding SOP, system and GCP questions of moderate complexity
• Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
• Perform impact assessments of new/revised local regulations, guidance and standards
• Support central functions in ensuring local intelligence is up to date (e.g., T-Race, IRON)
• Support LOC Management Review in collaboration with LOC Business Quality partners. Support local vendor assessments as appropriate
• Support annual Due Diligence update, certification and training of local vendors, if applicable

General Duties & Responsibilities:
• Overall accountability for planning, executing and monitoring of clinical trials through all phases of the trial feasibility through database lock, and inspection-readiness for assigned Therapeutic Area or study portfolio in country or for TCSM activities of specific role (s).
• Appropriate and timely issue escalation to line management and study team as appropriate. Report (suspicion) of fraud or scientific/ethical misconduct.
• Strong interaction with the R&D/Local Operating Company staff and departments within GCO and outside of GCO, i.e., (Regional Therapeutic Area Experts (RTAE), GCO Early Dev. & Clinical Pharmacology as applicable,, GCO Medical Affairs regional leadership, Central Trial Coordination (CTC), Integrated Data Services (IDS), Clinical Supplies Unit (CSU), Quality and Compliance (QC) and external vendor groups, Medical Affairs).
• Participates in special initiatives as needed and guides rollout of new processes and procedures
• Collaborates with the RTAE on country capabilities and study placement for assigned Therapeutic Area(s) or study portfolio.
• Accountable for study feasibility in country for assigned Therapeutic area or study portfolio.
• In some instances (i.e., smaller countries) backup to country leadership

Qualifications and experience of the successful candidate:
• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 5 years’ experience in the pharmaceutical industry, at a CRO or hospital including clinical research experience.
• Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable).
• Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Effective communication and leadership/people management skills and ability to foster team productivity and cohesiveness.
• Experience mentoring/coaching others. Ability to lead hiring, training, development and evaluation of people.
• Solid decision-making and financial management skills.
• Strong interpersonal skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
• Good conflict handling/negotiation skills.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Native level of Bulgarian, excellent English.

The Offer
• A unique opportunity to become part of the world-wide pharmaceutical leader
• A meaningful work giving a sense of accomplishment
• Possibility to participate on different projects and to have an impact
• Interesting financial remuneration
• Many employee benefits

If you are interested in this role and you fulfill the requirements set above, do not hesitate to send your CV and cover letter in English via Jobs.bg - https://www.jobs.bg/job/4644335