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Sr. Clinical Program Manager/Clinical Study Manager

Cambridge, MA

Posted: 05/10/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2348

Our client is looking to add a Sr. Clinical Program Manager or a Clinical Study Manager to its team on a contract basis. Depending on level of experience, this position will report to the Associate Director of Clinical Operations (or above). The right candidate will possess an understanding of Clinical Operations for successful execution of multiple clinical trials primarily in oncology and hematology indications in various phases of development.

Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team.

SR. CLINICAL PROGRAM MANAGER
Responsibilities Include:
  • As a Program level manager, manages across multiple studies and clinical operations aspects of a drug development program.
  • Independently manages and supervises of the operational aspects of clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
  • Leads vendor selection and development of work orders.
  • Provides mentoring to junior team members.
  • Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress
  • Assists in SOP and process development for Clinical Operations functions
  • Manages clinical program budgets, develops forecasts, and ensures execution program timelines.
  • Oversees the day to day supervision of clinical trial execution, with a focus on site  start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
  • Leads and develops content for investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • Leads the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
  • Presents trial status and clinical operations strategy to project team and management.
  • Reviews and approves specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Leads Clinical Operations project team meetings and participates in program strategy discussions
  • Reviews action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
  • Attends site visits to ensure oversight of CRO and KOL development.
  • Participates in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).

Requirements / Qualifications:
  • Bachelor’ s degree in a scientific discipline required. Advanced scientific degree is preferred.
  • The candidate should ideally have 5-8+ years in trial management with a sponsor company managing various phase clinical trials. 
  • Experience or exposure to clinical trial conduct in multiple phases of development across several therapeutic areas, including oncology, would be preferred.
  • Experience in CRO, vendor and laboratory selection and oversight is required.
  • Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
  • Creative problem solver with excellent communication and public speaking skills.
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.  Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
  • Ability to travel for up to 30% of time, both domestic and international, may be needed.
  • Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements a plus.

CLINICAL STUDY MANAGER
Responsibilities include:
  • Independent management of the operational aspects of clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
  • Identification and qualification of clinical trial sites and investigators alongside CRO including management of key relationships.
  • Participation in final decisions for site selection with Company team.
  • Participation in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
  • Management of clinical study budgets and execution timelines.
  • Leads internal team meetings for study management.
  • Facilitation of investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
  • Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
  • Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
  • Collaboration on SOP development and promotion of standardized clinical business tools.
  • Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
  • Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).

Requirements / Qualifications:

 
  • Bachelor’ s degree in a scientific discipline required. Advanced scientific degree is preferred.
  • The candidate should ideally have 4-6+ years in trial management with a sponsor company managing various phase clinical trials. 
  • Experience in various phases of clinical trials and various therapeutic areas, including oncology, would be helpful.
  • Experience in CRO, vendor and laboratory oversight is required.
  • Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
  • Creative problem solver with excellent communication and public speaking skills.
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.  Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
  • Ability to travel for up to 30% of time, both domestic and international, may be needed.
  • Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements a plus.

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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