Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

CSM (Clinical Study Manager):

OBJECTIVES: 

Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.

In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable):

• Support or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards on schedule and on budget.

• Oversee Strategic Partners and/or other CROs and other vendors to meet obligations described in ICH-GCP and business objectives.

Studies may include but are not limited to PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office), those in wind down, etc.  More than one study and/or more than one program may be assigned.

ACCOUNTABILITIES: 

• Accountable for planning and operational strategy and execution for assigned clinical trials

  • Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents

  • Challenges study team to ensure operational feasibility, inclusive of patient and site burden

  • Supports budget development and ensures impacts are adequately addressed

  • Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy

  • Develops and manages study timelines

  • Challenges study team to ensure timelines meet the needs of the clinical development plan

  • Ensures new team members and vendors are appropriately onboarded

  • Identifies and oversees trial risk and mitigation

  • Leader of the cross functional study team

• During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place

• Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly

• Supports/reviews study budget planning and management and accountable for external spend related to study execution.  Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs

• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;

• Specific areas of sponsor oversight include, but are not limited to:

  • Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring

  • Conduct Oversight Monitoring Visits, as applicable

  • Review and endorsement of relevant study plans, as applicable

  • Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes

  • Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study

  • Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies

  • Review and ownership of trial operational data (e.g. CTMS)

  • Review and provide oversight of internal trial reports

• In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. 

• Support data review for database lock and CSR writing and review (including appendices)

• Collect/review/File study documents in support of the trial master file (TMF) 

• Collect/review/File study documents in support of the regulatory filing

• Responsible for overseeing study financial reconciliation

• Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.

• Site relationship management

• Review and provide oversight of trial audits 

• Proper and timely follow up to audit findings and CAPAs 

• Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Education:  Bachelor’s Degree or international equivalent required; Life Sciences preferred.

Skills: 

• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.  Awareness of local country requirements is also required.

• Demonstrated successful experience in project/program management and matrix leadership

  • E.g. timeline/budget management

  • E.g. Risk identification and management

• Works independently and is highly organized

• Good communication skills

• Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with Leading cross-functional teams, vendor selection and oversight

• Experience managing recruitment challenges and boosting enrollment

• Fluent business English (oral and written)

Experience: 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA).  Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs.  Experience in more than one therapeutic area is advantageous.

Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.

TRAVEL REQUIREMENTS:

• Requires approximately 5-20 % travel, including overnight and international travel to other strategic partners, study sites, and therapeutic area required travel.