Sr. Clinical Study Manager/ Director - Clinical Operations in Cambridge, MA at APEX Systems

Date Posted: 11/7/2019

Job Snapshot

Job Description

Job #:  1023689
Senior Clinical Study Manager / Director - Clinical Operations 1023689
Job Scope & Purpose:
Our Cambridge based client is seeking an exceptional Sr. Clinical Study Manager which could flex to Director of Clinical Operations. This person will report to the Vice President of Clinical Operations and is expected to work hands-on to design and execute Phase I-IV oncology clinical studies to ensure their timely completion with quality data. This individual must have clinical operations expertise in all aspects of oncology studies especially Phase I studies. The Sr. Clinical Study Manager will manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. Apply now to learn more!
Primary Job Responsibilities:
  • Responsible for in-house execution of oncology clinical studies
  • Responsible for implementation and oversight of Phase I-IV trials
  • Assist in protocol development to ensure operational study requirements can be executed by clinical sites
  • Set study goals and timelines and manages vendor deliverables within timelines
  • Is accountable for developing, tracking and managing overall study budget
  • Actively involved with CRO partner and sites on all aspects of study start-up, enrollment and study completion. Proactively identifies and collaboratively addresses issues promptly
  • Provide regular updates to management as appropriate
  • Leads the evaluation, selection, and management of CROs. Owns relationship management with CRO, clinical sites and all vendors to ensure they are meeting expectations of successful clinical trial implementation, execution and on-time delivery of quality data
  • Oversight and quality management to ensure CRO meets timelines and budget
  • Timely review of monitoring visit reports and appropriate identification, escalation and solution of issues arising at clinical sites
  • Drives study objectives and times by having regular team meetings with internal study team, CROs and key vendor partners
  • Accountable for ensuring accurate and timely data cleaning/quality
  • Contribute to protocol development and study implementation
  • Lead interactions with CRO and investigators to refine and finalize protocols
  • Responsible for feasibility, investigator and site selection
  • In Collaboration with CRO, Conduct protocol and site feasibility assessments
  • Responsible for the writing and/or review of other study documents (including CSR, lab manuals, pharmacy manuals, CRFs, data management guidelines, etc.)
  • As needed, assists in preparation of regulatory submission packages
  • Effective staff management:
  • Staff are trained and current on GCP and ICH guidelines
  • Develop training plans for staff
  • Meet with Staff regularly to ensure projects are on time and budget and help address any issue. Manage and lead a team of clinical operations staff.
  • Responsible for infrastructure build for lead clinical trial programs, including inspection readiness.
  • Ability to build strong KOL, Principal Investigator and patient advocacy relationships,
  • Lead internal study management teams (SMT) to ensure timely and effective communication with all cross-functional staff.
  • Manage all aspects of study progress from planning to close-out to assure adherence to timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.
  • Attend scientific conferences as needed.

Primary Job Requirements:
  • Bachelor’s degree or equivalent in a scientific or healthcare discipline
  • 8+ years of clinical operations and study management experience with a focus in oncology, with at least 5 years’ hands-on clinical monitoring experience required
  • Hands-on experience in all aspects of clinical operation logistics and documentation from study start-up through study closeout in Phase I-IV studies.
  • Effective leadership of cross-functional study teams
  • Experience in project planning, and identifying and managing clinical study risk
  • Experience in setting and managing clinical trial budgets, CROs and can develop/review site selection strategies, clinical supplies management, sample management, conduct and monitoring of clinical studies, etc.
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.
  • Experience in managing and partnering with CRO’s to deliver a broad range of CRO services
  • Working knowledge of regulatory and ICH GCP guidelines
  • Demonstrated strong interpersonal skills to ensure a positive collaborative relationship with internal staff, investigators, patient advocacy groups and external CRO partners
  • Clinical operations supervisory experience in a Pharmaceutical or biotech company
  • Anticipated travel up to 10-20%

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Code: ClinOps
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.