Senior Clinical Trial Manager at Mallinckrodt Pharmaceuticals in Hampton, New Jersey

Job Description:

Job Title

Senior Clinical Trial Manager

Requisition

JR000011521 Senior Clinical Trial Manager (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Hampton, NJ

Job Description

Summary

The Senior Clinical Trial Manager (Sr. CTM) reports to the Associate Director/Director/Sr. Director, Global Development Operations and is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects.The Sr. CTM co-leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials in accordance with applicable laws, regulations and SOPs.. The Sr. CTM uses solid judgement and independent decision making to assess and manage technical study documents and key clinical management activities, and represents Global Development Operations on internal and external teams. The incumbent will work closely with other S&T Functional and Operational leaders to ensure alignment on trial related deliverables and communication regarding the status of trial related milestones. The Sr. CTM will mentor CTM and/or CTA level resources in support of expansion of the CTM/CTAs knowledge base of clinical operational activities.

The role also involves leading Global Development Operations initiatives with a focus on leveraging technology and industry best practices to run trials that are more efficient.. In support of this, the Sr. CTM is required to participate in external activities that expose them to new or enhanced ways of working e.g. attending relevant industry webinars/meetings, representing Mallinckrodt on industry work groups or panels.

Principal Responsibilities

• Management and oversight of all clinical trials related to a specific compound or development plan


• Develops and coordinates global clinical trial and operational activities and manages their execution to ensure completion according to project timelines and budget.


• Along with Clinical Development, coordinates and co-leads the clinical sub-team


• Participates in project core team meetings.


• Provides regular and timely updates on trial related activities to the Project Manager.


• Reviews and provides strategic operational input to protocols, protocol amendments, case report forms (CRFs), and clinical study reports (CSRs).


• Develops informed consent documents.


• Remains up to date on expectations regarding current Federal Regulations and Guidances, ICH/GCP and internal SOPs.


• Oversees the selection of investigative sites


• Leads the planning of r and presents at Investigator Meetings s


• Is responsible for creation of clinical trial timelines and enrollment projections,


• Participates in the vendor selection process, including leading the creation and review of the draft RFP, and review of returned RFPs, attending bid defense meetings, ensuring required audits are conducted , and works with Procurement to lead the final vendor selection meeting.


• Ensures creation of all trial related Plans e.g. Risk Management, Issue Management, TMF, Vendor Oversight and Management.


• Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget.


• Responsible for complete management and oversight of study level budget.


• Partners with the CRO to develop site level study budgets and approved variance ranges.


• Ensures internal and external team members assigned to a project are trained on the protocol and relevant MNK SOPs


• Reviews monitoring visit reports and ensures significant issues noted are followed through to resolution.


• Ensures study execution compliance with GCP/ICH and other applicable regulatory requirements.


• Works with Quality Assurance to facilitate scheduling of site audits and resolution of audit findings


• Partners with the Clinical Trial Associate to ensure the TMF is created, maintained, and archived


• Appropriately communicates project issues and emerging risks to the clinical sub-team and GDO leadership.

Department specific/Non-essential responsibilities:

• Leads GDO and/or S&T initiatives


• Participate in development and review of GDO SOPs


• Other duties as assigned with or without accommodation

Minimum Requirements

Experience / Skills:

Education required/ preferred:

BS or BA degree preferred. BSN/RN, or Bachelor's Degree in a science background is preferred.

Experience:

• At least 8 years of experience in a relevant clinical trial operation setting, within the pharmaceutical industry or a clinical research organization (CRO) is required.


• At least 5 years of experience in clinical trial management and execution is required.


• Previous monitoring, study coordination, data management experience including vendor/CRO management is preferred


• Knowledge of GCP, ICH and FDA regulations is required


• Experience managing Global Phase 1-4 clinical trials preferred


• Strong Project Management, clinical study management, analytical and problem solving skills


• Experience or able to mentor less experienced clinical team members


• Travel as needed to resolve field issues, provide training and meet with CRO partners


• Excellent interpersonal, oral and written communication skills

Competencies:

• Intermediate ability to effectively identify problems, trends, and/or root causes.


• Advanced development of risk management and/or remediation plans


• Developing ability to think innovatively surrounding situational analysis, and synthesizes information into clear conclusions. Develops and effectively communicates opinion with supportive rationale


• Analyzes data to support decision-making, and provides guidance to Team.


• Demonstrates advanced understanding of the drug development process including preclinical, clinical, regulatory, scientific, operational, regulatory and commercial aspects.


• Ability to manage the clinical operational aspects of more complex drug development projects and multiple teams.


• Possesses enhanced knowledge of clinical operations and the strategy(s) for the project/program.


• Demonstrates expanded understanding and knowledge of the drug and disease.


• Provides sound advice for product development teams to build the plan for product lifecycle management.


• Ensures high quality work is completed and has the ability to provide guidance to others within the functional area and that customer and vendor expectations are met.


• Develops quality expectations and developing ability to supervise others within the functional area.


• Actively develops and implements changes to improve quality within the functional area.


• Monitors the quality of a project/functional team while ensuring the effectiveness of procedures and processes.


• Manages the application of solutions where errors or inconsistencies have been identified and ensures project teams act accordingly.


• Ensures an understanding, and identifies and manages risks and manages issues through successful CAPA completion associated with Clinical Operations activities.


• Consistently demonstrates an ability to think innovatively in order to mitigate identified risks.


• Consistently demonstrates effective communication of risks and next steps at a Team level; and effectively communicates results.


• Works to prevent issues and risks and qualifies risks.


• Appropriately escalates issues to supervisor and seeks advice

Organizational Relationship/Scope:

Reports to Associate Director/Director/Sr. Director, Clinical Operations

Working Conditions:

• Normal office conditions


• Travel of approximately 35% is required for Investigator meetings, CRO oversight site visits, vendor meetings, conferences. Travel may be global as necessary.

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