Clinical Project Manager

Department: Clinical Operations
Date: 4/8/19
Reports to: Sr. Clinical Project Manager or Vice President, Clinical Operations
Supervises: Clinical Trial Associate


Position Summary:

Reporting to the Sr. Clinical Project Manager or Vice President Clinical Operations, this position coordinates various multi-disciplinary functions to meet clinical trial objectives.  With the goals for the entire development program in mind, may provide contributions to the strategic design and execution of a clinical trial program.  The CPM continuously evaluates the progression, quality, and cost of the various operational steps involved in planning and execution of a large, moderate complexity clinical trial or a few smaller trials.  Additionally, with minimal oversight, (s)he formulates corrective actions for identified issues and drives the implementation thereof.

At the departmental level, the CPM will contribute to the development and revision of relevant SOPs and internal processes.  The CPM will formulate recommendations to Clinical Operations leadership on problems as they arise.  The CPM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues and may manage a direct report.


General Responsibilities and Required Skills:

  • Strong study management track record showing clear proficiency in clinical project management skills

  • Solid vendor management skills

  • Broad understanding of Clinical Operations including those in related development functions

  • Demonstrates detailed understanding of assigned clinical protocol(s), intended study populations, as well as solid overall drug development

  • Demonstrates ability to effectively interface with internal and external key stakeholders

  • Demonstrates ability to lead multi-disciplinary teams

  • Possesses excellent written and oral communications skills 

  • Displays project leadership qualities

  • Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents

  • Proactively seeks out and recommends process improvements

  • Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight

  • Mentors and may supervise junior staff; takes a leadership role in onboarding new personnel

  • May contribute to Clinical Development Plans with oversight

  • Escalates issues in a timely and appropriate manner

 
Key Responsibilities:

Oversee clinical trial planning

  • May contribute to clinical development planning as it relates to operational considerations

  • Develops operational study implementation and execution strategy with minimal oversight

  • Identifies resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); leads or participates in the request for proposal process including defining expectations and deliverables; assesses qualifications and experience, and participates in final selection process

  • With minimal oversight, defines site qualification criteria and oversees the identification of potential investigators and clinical sites; oversees, performs or participates (as needed) in pre-study site visits, reviews evaluative reports; participates in the final selection of study sites

  • With minimal oversight, defines the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with VP Clinical Operations and/or relevant internal departments (as necessary)

  • With minimal oversight, develops Program/Study/Investigator Budgets, and performs ongoing analysis related to study progress and/or work being performed by outside vendors (CROs, CRAs, centralized laboratories, etc.)

  • Oversees and participates in Investigator Meetings

  • Ensures timely development of clinical trial documentation (e.g. informed consent documents, case report forms {CRFs}, CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc.)

  • Develops relationships with Investigators

  • Assesses project related internal/external educational needs with minimal oversight

  • Assesses study drug requirements and shipment logistics; may contribute to study product labeling strategy.

  • With minimal oversight, develops trial oversight plan for Clinical Operations; ensures Data Management and Safety Oversight plans are developed; ensures appropriate sponsor oversight documentation is generated

  • Leads cross-functional internal study execution team

  • Manages oversight of CRO and other vendors

Oversee study execution

  • Assesses adequacy and comprehensiveness of study / program tracking systems

  • Responsible for management, tracking and reporting of budget, timelines, all performance metrics and quality of deliverables in a clinical trial(s)

  • Manages and ensures appropriate level of sponsor oversight of CROs and vendors, ensuring adequate follow up, resolution, and documentation of identified issues with minimal oversight

  • Identifies and evaluates issues related to the project and coordinates resolutions

  • Continuously evaluates compliance to applicable SOPs and the quality of site monitoring and associated documentation; develops corrective action plan if indicated

  • Conducts risk management assessments throughout the life of the trial, proposing mitigation strategies as necessary

  • Ensures appropriate transmission of CRF data to data management team and reviews queries as necessary

  • Identifies data deficiencies and discrepancies, and coordinates corrective action as required

  • Participates in study data review and assists with patient narrative writing and other data review activities as assigned

  • Ensures adequate Serious Adverse Event reporting including documentation, tracking, and follow-up

  • Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards

  • Oversees close-out processes and ensures final site issues are addressed appropriately

  • Coordinates CSR writing, review, and approval process including the compilation of all required sections

  • Drives successful study completion

Other

  • Contributes to the development and continuing process improvement of relevant SOPs and internal processes

  • May be responsible for managing a direct report

  • Other duties as assigned

Minimum Qualifications:

  • Bachelors’ degree in scientific/clinical related discipline is required

  • At least 5 years of experience in a clinical research industry setting with a minimum of 2 years of clinical project management, including CRO oversight/management of a Phase 3 study

  • Solid understanding of industry standards including ICH guidelines, GCP, compliance, and the CFR

  • Functions independently with some oversight and willing to “wear many hats”

  • Local within commuting distance so can come to office occasionally

  • Strong communication, writing and presentation skills

  • Ability to foster effective relationships with vendors, investigators, and colleagues

  • Strong critical thinking skills

Preferred Qualifications:

  • 6+ years of relevant industry experience

  • Has managed and led multiple cross-functional processes involved in Clinical Research, specifically trial management

  • Knowledge of the infrastructure and operational characteristics of CROs and centralized services

  • Solid technical knowledge in the various aspects of the clinical trial process

  • Has contributed to the success of planning and execution of clinical trials in support of an overall clinical development plan

  • Proficient in development of clinical trial documentation (e.g. informed consent documents, case report forms {CRFs}, CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc.)

  • Understands the roles/responsibilities and inter-dependencies for key functions involved in clinical development

  • Familiarity with study / program tracking systems

  • Solid vendor management experience, including oversight of CROs

  • Small pharma experience preferred

  • Experience with pain or CNS trials

Work Environment: Office
Physical Demands: Occasional overnight travel

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

To apply, please send an email with your resume and cover letter to hr@neurobopharma.com.