SUMMARY: The Site Start-up Manager is responsible for overseeing Site Contracts and Site Document Specialists in the development, dissemination, negotiation, and finalization of clinical study (investigator) agreements, site essential regulatory documents, Start-up activities, and related documents between sponsors and clinical research sites.
Tasks may include but are not limited to:
Serves as a direct Line Manager to all Site Start-up staff located in, or responsible for, start-up activities (contracts and documents) in the region assigned to.
Manages project plans and timelines with regard to site contract and regulatory/start-up responsibilities in the designated region.
Assists the Global Clinical Operations Site Management and Project Management team and other company divisions in the development and maintenance of departmental processes, policies, SOPs and associated documents.
Serves as a project liaison to Sponsors and internal WCT Project Management teams to monitor study status, provide frequent region-specific metrics and status updates as needed.
Works closely with the clinical trial team to ensure delivery of site essential documents and fully executed contracts in support of timely study start-up to meet departmental goals.
Liaise between clinical service groups (SMO, Investigator sites), legal and clinical trial teams.
Collaborates with sponsor, clinical trial team and Investigational sites to verify and develop budget and negotiate cost savings.
Evaluates potential investigator sites from a financial and historical study start-up time perspective for critical site feasibility and selection, to provide input for investigator selection decisions.
Maintain proactive business planning and support to ensure that all financial requirements are satisfied.
Provides second level QC review, when needed, of final site agreements and essential documents required for site activation/IP release.
Provides ongoing mentorship and training to Start-up staff as needed.
Maintains a reduced billable site workload, working directly on site agreement negotiations and/or essential documents.
Assists Global Clinical Operations Site Management and/or other company departments in leading or participating in department initiatives, tasks forces, and additional training where necessary.
Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
Extensive knowledge regarding local requirements within the assigned region in regards to site contract negotiations, site documents/ethics requirements, start-up strategies, and approval timelines associated within this region.
Excellent organizational and customer service skills.
Ability to review and understand technical and medical documents.
Familiarity with RFPs and Proposals for investigator contracts services including bidding process and scope of work.
Ability to work on complex, multi-faceted projects.
Excellent communication skills, including negotiation skills and knowledge of clinical trial agreements and site documents.
Computer literacy with document and spreadsheet applications.
Bachelor's Degree or equivalent in Business administration, finance, science or related field.
Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements.
Knowledge and understanding of ICH and GCP Guidelines, as well as local regulatory requirements.
Excellent spoken and written English language skills.
High degree of organizational, analytical, and team management skills.
1-3 years of experience in Contract Agreement negotiations.
1-3 years of experience in Site Documents/Regulatory Affairs or ethics submissions.
1-2 years of previous Line Management experience.
About Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...