Clinical Trial Manager/ Senior Clinical Trial Manager

Position Summary: Serves as the clinical trial lead responsible for the planning, conduct and oversight 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 all applicable regulatory requirements.

Essential Functions:

• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study related 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 develop 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
• Develop and finalize the country recruitment/retention strategy
• Develop 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 close out procedures
• Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
• Address all 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
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• Develop 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 develop 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 when 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
• When 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 contracts 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 perform clinical data review of patient profiles, data listings and summary tables, including query generation
• 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-related 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 Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills to effectively interface 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 integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead 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

Compensation & Benefits: Precision ist gesetzlich verpflichtet, in einigen Bundesstaaten oder Städten eine angemessene Schätzung der Gehaltsspanne für diese Rolle anzugeben. Diese Gehaltsspanne berücksichtigt die Vielzahl von Faktoren, die bei der Festlegung von Vergütungsentscheidungen berücksichtigt werden, einschließlich, aber nicht beschränkt auf: Fähigkeiten, Erfahrungen und Schulungen, Lizenzen und Zertifizierungen sowie andere geschäftliche und organisatorische Bedürfnisse. Die offengelegte Schätzung wurde nicht um den geografischen Unterschied angepasst, der mit dem Standort verbunden ist, an dem die Position besetzt werden kann. Bei Precision ist es nicht üblich, dass eine Person in der Nähe des oberen Endes der Spanne für ihre Rolle eingestellt wird, und Vergütungsentscheidungen hängen von den Fakten und Umständen jedes Einzelfalls ab. Diese Rolle ist auch berechtigt für einen diskretionären jährlichen Bonus, Krankenversicherung, Altersvorsorgeleistungen, Lebensversicherung und Invaliditätsleistungen, Elternzeit und bezahlte Freizeit für Krankheitsurlaub und Urlaub, unter anderem.

Gehaltsspanne: $110,700—$200,900 USD

Gleichberechtigte Beschäftigung: Precision Medicine Group ist ein Arbeitgeber, der Chancengleichheit bietet. Einstellungsentscheidungen werden ohne Rücksicht auf Rasse, Hautfarbe, Alter, Religion, Geschlecht, sexuelle Orientierung, Geschlechtsidentität, nationale Herkunft, Behinderung, Veteranenstatus oder andere gesetzlich geschützte Merkmale getroffen.