1107# Senior Project Manager -Biometrics
About the role
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
ClinChoice is searching for a Senior Project Manager in Biometrics to join our Inhouse team.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Job Duties
- Independently manages Biometrics project teams from study start-up through study closeout; departments include but not limited to, Data Management, Biostatistics, Statistical Programming, and Medical Writing.
- Promotes team building & communication to ensure effective team functions.
- Manages multiple and complex projects, ranging in phase and number of Biometrics services involved.
- Serves as the primary liaison between clients, vendors, and project teams.
- Establishes and maintains relationships between clients, vendors and project team, to encourage repeat and/or new business.
- Encourages cross-functional collaboration to ensure deliverables are provided on time, with quality and within budget.
- Generates and maintains project timelines, milestones, and action items.
- Coordinates and leads project team meetings and creates and distributes agendas and minutes.
- Collaborates with finance, manages project financials; manages project budgets, generates monthly accruals, forecasts future accruals and initiates timely invoice generations.
- Proactively identifies out of scope activities and executes necessary change orders.
- Recognizes project issues and facilitates issue resolution; escalates issues, when needed.
- Implements identification of risks, mitigation, management and resolution.
- Participates in the preparation of governance meetings and attends, when needed.
- Provides performance feedback of team members to respective line managers, project teams.
- Provides mentoring and coaching, and oversees junior staff on PM processes, daily PM related tasks, and working on projects.
- Supports the generation and review of contracts (SOW, WO, COs, etc.).
- Confirms required project trainings are completed by team; company wide, client specifics and project specifics.
- Supports the preparation of audits, internal and external, and CAPA completion as required
- Contributes in business development activities; support in preparation of proposals and bid defenses. Works with the contracts team to generate the scope of work and budgets.
- Participates in departmental initiatives and SOP development/review and update.
- Develops and refines processes which lead to greater efficiencies or competitive advantages.
- May develop and refine project management processes within the Company.
- Performs other tasks as assigned by Sr. Management team.
Qualifications
- Bachelor’s degree or higher in life sciences. 5+ years of experience in Pharma/CRO industry with 8+ Years’ experience in Project Management.
- Excellent understanding of Biometrics services and processes and inter-dependencies.
- Preferable experience in a prior position in Biometrics and/or managing projects across Biometrics functional areas.
- Ability to solve problems, multitask and work independently with general directions.
- Knowledge of FDA regulations, drug development and PM processes.
- Good understanding of ICH/GCP guidelines.
- Strong presentation and communication skills, both oral and written.
- Strong team player, interpersonal skills, and customer focused.
- Flexibility to handle multiple tasks and deadlines.
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook.
- MBA or PMP certification is preferred.
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection. #TT1 #Senior#Contract
About ClinChoice
ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25 year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.
1107# Senior Project Manager -Biometrics
About the role
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
ClinChoice is searching for a Senior Project Manager in Biometrics to join our Inhouse team.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Job Duties
- Independently manages Biometrics project teams from study start-up through study closeout; departments include but not limited to, Data Management, Biostatistics, Statistical Programming, and Medical Writing.
- Promotes team building & communication to ensure effective team functions.
- Manages multiple and complex projects, ranging in phase and number of Biometrics services involved.
- Serves as the primary liaison between clients, vendors, and project teams.
- Establishes and maintains relationships between clients, vendors and project team, to encourage repeat and/or new business.
- Encourages cross-functional collaboration to ensure deliverables are provided on time, with quality and within budget.
- Generates and maintains project timelines, milestones, and action items.
- Coordinates and leads project team meetings and creates and distributes agendas and minutes.
- Collaborates with finance, manages project financials; manages project budgets, generates monthly accruals, forecasts future accruals and initiates timely invoice generations.
- Proactively identifies out of scope activities and executes necessary change orders.
- Recognizes project issues and facilitates issue resolution; escalates issues, when needed.
- Implements identification of risks, mitigation, management and resolution.
- Participates in the preparation of governance meetings and attends, when needed.
- Provides performance feedback of team members to respective line managers, project teams.
- Provides mentoring and coaching, and oversees junior staff on PM processes, daily PM related tasks, and working on projects.
- Supports the generation and review of contracts (SOW, WO, COs, etc.).
- Confirms required project trainings are completed by team; company wide, client specifics and project specifics.
- Supports the preparation of audits, internal and external, and CAPA completion as required
- Contributes in business development activities; support in preparation of proposals and bid defenses. Works with the contracts team to generate the scope of work and budgets.
- Participates in departmental initiatives and SOP development/review and update.
- Develops and refines processes which lead to greater efficiencies or competitive advantages.
- May develop and refine project management processes within the Company.
- Performs other tasks as assigned by Sr. Management team.
Qualifications
- Bachelor’s degree or higher in life sciences. 5+ years of experience in Pharma/CRO industry with 8+ Years’ experience in Project Management.
- Excellent understanding of Biometrics services and processes and inter-dependencies.
- Preferable experience in a prior position in Biometrics and/or managing projects across Biometrics functional areas.
- Ability to solve problems, multitask and work independently with general directions.
- Knowledge of FDA regulations, drug development and PM processes.
- Good understanding of ICH/GCP guidelines.
- Strong presentation and communication skills, both oral and written.
- Strong team player, interpersonal skills, and customer focused.
- Flexibility to handle multiple tasks and deadlines.
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook.
- MBA or PMP certification is preferred.
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection. #TT1 #Senior#Contract
About ClinChoice
ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25 year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.