Title: Study Start-up Manager
Department: Country Clinical Operations
Location: Mississauga Head Office or SSF Head Office
The Study Start-up Manager is responsible for leading and managing the Study Start-up Team, so that its members are adequately trained and comply with the high level of quality required in the activities they perform. The Study Start-up Manager is an expert in all activities related to the start-up of clinical studies in North America, ensures that the study start-up activities, including budget and contract negotiations and activities involving collaboration with third parties involved in clinical research, are carried out correctly, and acts as the leader in local/global study start-up process improvements.
1. Manage the local Study Start-Up Team
- Maximize productivity and contribution of the local Study Start-up Team, through effective management of performance, communications and relations, as well as the development and training of individual personnel.
- Guarantee that every local Study Start-Up Specialist knows their area of responsibility and specific functions.
- Identify future resource needs. Recruit, train and develop the appropriate talent.
- Develop strategies for the Study Start-Up Specialists based on the global objectives and identified areas for improvement.
2. Ensure the correct execution of study start-up activities
- Coordinate, guide and assist in all the start-up activities prior to the site's activation.
- Be up to date in the related regulatory knowledge to guarantee adherence and compliance with regulatory requirements and the corresponding / related documentation.
- Keep the available data (metrics), to ensure that the processes are carried out, efficacy is promoted, and times are reduced in the study start-up phase and in contract negotiations.
- Ensures that the information and requirements of the study start-up phase are updated and available at the central repository for the global and local study teams.
3. Stakeholder Management
- Keeps updated and informed of the changes in the clinical study start-up process in government, in research sites and in the industry in general and cascade this information with the Study Start-up Team.
- Ensures that all information requested by the Regulatory Authorities / Industry Bodies/ EC is provided as appropriate and in a timely manner.
- Ensure continuous and proactive communication with the Ethic’s Committees/Hospital Administration/Industry Bodies, in order to obtain precise and updated information on the status and activities of clinical studies.
- Act as country representative in the SSU network within the region / organization.
4. Identification of new sites
- Assist Study Start-up Specialist with identification of new sites and feasibility process for US and Canadian sites
- Ensure Study Start-up Specialist are trained on feasibility process
- Support and train Study Start-up Specialist on US and Canadian contract and budget negotiation process.
- Ensure the correct budget negotiation with the study sites.
- Ensure adherence to FMV (Fair Market Value) for all clinical trials costings and payments.
- Ensure cost effectiveness and development of global / local tools and templates that facilitate this in the affiliates.
- University Degree or Equivalent preferably in a medical/science-related field.
- Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.
- Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
- Decision making - Pushes decision making to the lowest appropriate level and develops employees’ confidence in their ability to make those decisions
- Encourages direct and open discussions about important issues.
- Managing change - Effectively manages change; explaining the context, answering questions, and patiently listening to concerns
- Teamwork collaboration - Finds and attracts highly talented and productive people
- Achieving results - Clearly conveys objectives, deadlines and expectations
- Ability to present clear messages accurately in both written and spoken English from complex information/data to all levels in the organization
Qualified candidates are encouraged to submit cover letter and resume no later than November 3, 2019.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in the country of application.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process
AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.