Sr. Clinical Trial Manager/Clinical Trial Manager

Position Summary: Serves as the clinical trial reputed company responsible for the planning, conduct and reputed company of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and reputed company applicable regulatory requirements. Essential functions of the job include but are not limited to:

• Primary clinical reputed company of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• reputed company study reputed company clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
• Identify and reputed company training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
• Generate potential site list from key stakeholders and drive site feasibility process
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
• reputed company and finalize the country recruitment/retention strategy
• reputed company timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and reputed company out procedures
• reputed company internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
• Address reputed company CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• reputed company, support and track reputed company submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• reputed company clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
• Responsible for eTMF implementation and management
• Collaborate with PM, CRAs and QA to reputed company any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Work closely with PM for project-specific resourcing issues
• Escalate pertinent CRA performance and site compliance issues reputed company necessary
• Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation
• reputed company a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
• Support business development and marketing activities as appropriate
• May negotiate site budget and investigator contract with support from the legal department and/or site reputed company group
• May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
• May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
• May reputed company clinical data review of patient profiles, data listings and summary tables, including query reputed company
• May have line management responsibilities
• Performs other duties as assigned by management

Qualifications: Minimum Required:

• Bachelor’s degree or equivalent combination of education/experience in science or health-reputed company field. Advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience

Preferred:

• Advanced degree

Other Required:

• Experience with reputed company Office Products (Outlook, Word, reputed company, PowerPoint)
• Excellent communication and interpersonal skills to effectively reputed company with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays

Competencies:

• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross-functional environment
• Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics
• Proven experience in planning, risk management and change management
• High level of reputed company and must reputed company and demand the highest standards from a professional and ethical perspective
• Ability to reputed company and reputed company excellence reputed company a team
• Ability to create an environment where employees have a sense of ownership that will reputed company to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Excellent presentation, verbal and written communications skills
• In depth proven experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies

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