• Manages project-specific work of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) in the execution of operations, and ensures compliance with GCP, regulations, and procedures.
• Promotes operational efficiency, teamwork and high morale amongst CTAs and CRAs.
• Provides input on protocol design and operational aspects of the trial.
• Develop clinical monitoring plans and informed consent documents and study tools.
• Oversees clinical monitoring activities and develops strategies for assuring quality deliverables.
• Reviews monitoring visit reports and adherence to timelines for report submission and finalization.
• Develop study-specific CRA training materials. 
• Trains CRA team and tracks and maintains documentation of training throughout the life of the project.
• Acts as mentor and co-monitor with CRAs to ensure high quality of deliverables.
• Works closely with line management and project CPM for resourcing
• Supports CRAs with difficult and/or challenging sites, and provides necessary intervention, including direct site contacts or on-site visits.

Skills: Clinical Operations Management, Regulatory Compliance, Protocol Development, Quality Assurance, Training and Development, Team Leadership, Problem-Solving and Intervention, Collaboration and Communication

• Creates site screening tool for country feasibility with Clinical Trial Manager and Clinical Program Leader
• Escalates pertinent CRA performance and site compliance issues to clinical program management
• Leads clinical site start-up activities, such as site selection, site budget negotiations, and contract execution (support clinical finance), regulatory document collection, and IRB approval.
• Monitors the status of site budget and contract negotiations
• Tracks monthly clinical trial operations expenses and provides to CPM.
• Proactively communicates clinical operations updates/issues to the CPM & Clinical Affairs project team.
• Drives trial conduct and reviews trial activities/enrollment to identify trends/issues related to CRA and site activities
• Ensures operational aspects are on schedule.
• Generates and utilizes metrics tools to ensure the study is running per timelines and to alert CRAs and Clinical Program Management to potential operational issues.
• Leads clinical operations meetings

Skills: Clinical Trial Site Management, Performance Monitoring and Issue Escalation, Budget and Contract Management, Communication and Coordination, Operational Oversight, Metrics and Tools Utilization, Leadership in Meetings, Regulatory Compliance and Documentation

• Provides direct operational input into protocol development to ensure efficient and effective delivery of trial objectives
• Communicates protocol information including changes or amendments to vendors for implementation
• Ensures trial operational plans (e.g. project management plan, communication plan, risk management plan, etc.) are developed by the vendors with inputs from CTT
• Develops and executes operational risk management plan highlighting potential risks and actions
• Foresees internal and vendor resource gaps and escalates in a timely fashion
• Creates and drives trial-level timelines
• Ensures all trial deliverables are met with high quality on time and within budget
• Provides trial updates at relevant internal/external boards
• Ensures all trial-related documents and systems (e.g. clinical database, IRT, etc.) required for Ethics/Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines
• Develop trial-level training materials with the relevant members of the CTT and vendors for project team training, Investigator Meetings, Monitor Training, and Site Initiation
• Accountable for trial allocation to ensure optimal patient accessibility, resource allocation, and country development

Skills: Protocol Development and Management, Effective Communication and Coordination, Operational Planning and Risk Management, Project Management and Timeline Creation, Resource and Gap Analysis, Regulatory and Documentation Compliance, Training and Development, Operational Oversight and Allocation

• Attends and participates in Clinical Affairs team meetings as a clinical operations representative.
• Maintains strong knowledge of the protocol to answer operational questions from CRAs and sites.
• Works with Clinical Program Management to identify and manage CROs and study suppliers
• Presents and participates in Investigator Meetings, other study training and meetings
• Manage and review/complete quality control (QC) of Project Trial Master File (TMF).
• Recommends and implements continuous process improvement ideas for clinical operations.
• Ownership and regular contributor to the development and revision of clinical operations and study management documents
• Builds allocation scenarios based on feedback from vendors, and ensures approval from the Business Team on the final trial allocation
• Ensures trial-level and site-level readiness for first-site initiation
• Plans to drive and facilitate investigator meetings or equivalent investigator training with CTT and vendors
• Drives vendor selection and start-up with CTT and Indirect Purchasing

Skills: Clinical Operations Expertise, CRO and Supplier Management, Quality Control (QC) Management, Process Improvement Implementation, Clinical Documentation Development, Allocation Scenario Building, Investigator Meeting Facilitation, Vendor Selection and Start-Up

• Execute and oversee the local clinical trial activities for assigned protocols in compliance with ICH/GCP and German regulations, client policies and procedures, quality standards and adverse event reporting requirements
• Own both country and site budgets, negotiate and close Clinical Trial Research Agreements
• Oversee and track payments, reconcile payments at study close-out and ensure accurate data in financial systems
• Manage and coordinate local processes such as clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management and data quality
• Execute and oversee country submissions and approvals
• Collaborate with Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and other regulatory authorities
• Contribute to the development of local materials and best practices
• Collaborate closely with other internal and sponsor departments to ensure all country deliverables are met and aligned with timelines
• Manages and oversees vendor activities and interactions during the conduct of the trial to ensure adherence to the signed contract and agreed-on timelines and budget
• Reports and assesses vendor performance ongoing during the trial
• Collaborates with Clinical Trial Supply Management and vendors to ensure all aspects of the IMP and non-drug supplies are managed throughout the trial

Skills: Clinical Trial Management, Budget Management, Regulatory Compliance, Vendor and Supply Chain Oversight, Process Coordination, Documentation and Archiving, Collaboration and Communication, Quality Assurance

• Provide training and coaching to healthcare professionals and scientists.
• Track major milestones of the trial and highlight any concerns immediately
• Create and maintain training protocol documents
• Ensure compliance with regional and international regulations
• Providing trial-specific training for the team as well as a broader nursing network
• Liaising directly with Sponsors, as well as managing a team
• Support business with proposals, feasibility and strategy
• Create and manage trial-level budgets
• Work cross-functionally with internal/external stakeholders to ensure clinical program timelines and goals are met
• Provide study-specific mentoring and line management for junior team members
• Assume leadership role in operational improvement initiatives
• Facilitate the development of clinical trial agreements in conjunction with legal group 

Skills: Training and Coaching, Regulatory Compliance, Project Management, Protocol Development, Stakeholder Engagement, Budget Management, Leadership and Mentoring, Proposal and Strategy Support

• Experience working with Clinical research
• CRA-level working experience (both CRO and industry experience)
• Lead CRA/CTL working experience
• Excellent verbal and written communication, and presentation skills
• Excellent interpersonal and organizational skills with attention to detail
• Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint
• Strong critical thinking, problem-solving and analytical skills
• Ability to efficiently organize and prioritize tasks within a multifaceted framework and set deadlines
• Excellent documentation skills
• Be a member of ACRP/ICR/SoCRA

Qualifications: BS in Clinical Research with 5 years of Experience

• Clinical research/monitoring experience or equivalent combination of education, training and experience.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Good knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
• Proven ability to understand customer needs and appropriately influence decision-making
• Effective mentoring and training skills
• Ability to balance operational and strategic priorities
• Strong communication and interpersonal skills, including a good command of the English language
• Effective presentation skills

Qualifications: BS in Pharmaceutical Sciences with 6 years of Experience

• Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge
• Competent in clinical trial planning and metrics management
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Proficiency at analyzing data and information to make conclusions and drive sound decision-making
• Ability to maintain excellent working relationships with a broad range of trial staff
• Ability to work well in a team environment but also independently without significant oversight
• Drug Development and Regulatory Approval Processes (depending on applicable territory(ies)
• Strong computer acumen in technology applications, including the use of eTMF, EDC, CTMS, site EMR systems, etc.
• Strong leadership skills, self-motivated, adaptable to a dynamic and fast-paced environment

Qualifications: BS in Biomedical Science with 4 years of Experience

• Experience working as a Clinical Research Associate III
• Excellent communication skills with strong presentation skills
• Proficiency in written and spoken English, fluent in the host country's language
• Expert knowledge of relevant clinical research regulations and ICH-GCP
• Ability to establish/maintain good relationships with sites/colleagues/clients
• The ability to make decisions independently 
• Strong problem-solving skills
• Highly developed mentoring and motivational skills
• Previous CRO working experience
• Good experience in CTMS, eTMF IXRS and EDC systems

Qualifications: BS in Nursing with 3 years of Experience

• Working experience in clinical research management 
• Working experience in managing a project budget
• Experience in a monitor role or a role overseeing clinical trials 
• Strong Interpersonal skills
• Strong Project Management and Leadership skills
• The ability to work under pressure
• Ability to work in a matrix environment
• Displays innovative ideas and solutions
• Highly proficient in negotiation skills
• Highly effective in influencing others

Qualifications: BS in Biotechnology with 2 years of Experience

• Previous data entry working experience 
• Excellent attention to detail.
• Good organization and planning skills
• Demonstrated analytical skills and ability to identify problems and solutions independently
• Ability to collaborate with the study team, cross-functional team members and external collaborators
• Proficiency in MS Word, Excel and PowerPoint. Previous computer experience is required.
• Strong interpersonal skills and communication skills (both written and oral)
• Strong leadership skills, self-motivated, adaptable to a dynamic and fast-paced environment
• Must have excellent organizational and time management skills.
• Ability to prioritize and handle multiple tasks and projects in a fast-paced environment

Qualifications: BS in Health Sciences with 5 years of Experience