Director, Clinical Operations - CRO - North America
Company Name:
Mapi, Inc
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
Mapi is the global leader in Patient-Centred Research services including Real-World Evidence, Post-Approval, Registries, Linguistic Validation, Health Economics, Strategic Market Access and through the Mapi Research Trust; the largest library of Clinical Outcome Assessments.
With 40 years of experience in administering and developing insight from Real-World Evidence. Mapi supports Life-Science companies, Government Funded Health agencies, Health Technology Assessment (HTA) providers, Accountable Care Organizations (ACOs) and Regulatory bodies in gathering and evaluating data on Therapies, Pharmaceuticals, Biologicals, and Medical devices.
Mapi is seeking a Director, Clinical Operations to lead our North American Clinical Operations team! This key leadership role will report to our Vice President, Operations, Americas and will require national as well as international travel.
The Director, Clinical Operations is responsible for supervising Clinical Operations activities (including Regulatory Affairs, Monitoring & Site Management, Records Management) on projects in accordance with protocol specifications, applicable guidelines, regulatory requirements, and SOPs.
Responsibilities include:
Responsible for resourcing, managing and developing the department.
Responsible for developing and monitoring departmental objectives and performance metrics in accordance with the approved, established departmental budgets.
Responsible for building effective relationships with all Mapi departments.
Responsible for partnering with the management team for strategic planning, development, and implementation of company objectives, initiatives, and internal projects.
Responsible for providing accurate and timely department status update to management team.
Responsible for hiring, coaching, promoting staff in collaboration with senior staff of the department and for projecting and allocating appropriate resources within the department.
Responsible for assisting project teams in problem resolution.
Responsible for providing business development support for request for proposals, budgets, bid defenses and other opportunities as needed.
Responsible for promoting and fostering professional and collegial internal and external client relationships.
Responsible for providing input and oversight for enhancement of tools used by the department.
Responsible for developing and maintaining Standard Operating Procedures related to the department, for representing the department in sponsor audits and for implementing corrective or preventive actions for department issues or audit findings.
Participate in the improvement of the Quality Assurance System.
Completing other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs.
Qualifications:
Education/
Experience:
Four (4) year college degree in a scientific discipline or health related field or an equivalent combination of education and work experience required.
Minimum Six (6) years of relevant experience in a CRO, Clinical Research Corporation, pharmaceutical company, or biotechnology company required.
Supervisory or technical management experience including leading teams, training and mentoring staff is required.
Knowledge/Skills/Attributes:
Excellent knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP ) and local requirements.
Proficiency with computer/software systems.
Excellent verbal, written communication skills and presentation skills.
Excellent organizational, time management, interpersonal, listening, conflict management and negotiation skills.
Ability to prioritize and coordinate multiple tasks and produce quality results in a timely manner with minimal supervision.
Ability to proactively identify issues and address/escalate as appropriate.
Ability to work both independently and in a team environment.
For non-native English speakers: possess excellent skills in written and spoken English.
To apply, click here: http://mapigroup.com/careers/director-clinical-operations-north-america/
As an Equal Opportunity Employer, Mapi is committed to a diverse work force.Estimated Salary: $20 to $28 per hour based on qualifications.
Mapi, Inc
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
Mapi is the global leader in Patient-Centred Research services including Real-World Evidence, Post-Approval, Registries, Linguistic Validation, Health Economics, Strategic Market Access and through the Mapi Research Trust; the largest library of Clinical Outcome Assessments.
With 40 years of experience in administering and developing insight from Real-World Evidence. Mapi supports Life-Science companies, Government Funded Health agencies, Health Technology Assessment (HTA) providers, Accountable Care Organizations (ACOs) and Regulatory bodies in gathering and evaluating data on Therapies, Pharmaceuticals, Biologicals, and Medical devices.
Mapi is seeking a Director, Clinical Operations to lead our North American Clinical Operations team! This key leadership role will report to our Vice President, Operations, Americas and will require national as well as international travel.
The Director, Clinical Operations is responsible for supervising Clinical Operations activities (including Regulatory Affairs, Monitoring & Site Management, Records Management) on projects in accordance with protocol specifications, applicable guidelines, regulatory requirements, and SOPs.
Responsibilities include:
Responsible for resourcing, managing and developing the department.
Responsible for developing and monitoring departmental objectives and performance metrics in accordance with the approved, established departmental budgets.
Responsible for building effective relationships with all Mapi departments.
Responsible for partnering with the management team for strategic planning, development, and implementation of company objectives, initiatives, and internal projects.
Responsible for providing accurate and timely department status update to management team.
Responsible for hiring, coaching, promoting staff in collaboration with senior staff of the department and for projecting and allocating appropriate resources within the department.
Responsible for assisting project teams in problem resolution.
Responsible for providing business development support for request for proposals, budgets, bid defenses and other opportunities as needed.
Responsible for promoting and fostering professional and collegial internal and external client relationships.
Responsible for providing input and oversight for enhancement of tools used by the department.
Responsible for developing and maintaining Standard Operating Procedures related to the department, for representing the department in sponsor audits and for implementing corrective or preventive actions for department issues or audit findings.
Participate in the improvement of the Quality Assurance System.
Completing other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs.
Qualifications:
Education/
Experience:
Four (4) year college degree in a scientific discipline or health related field or an equivalent combination of education and work experience required.
Minimum Six (6) years of relevant experience in a CRO, Clinical Research Corporation, pharmaceutical company, or biotechnology company required.
Supervisory or technical management experience including leading teams, training and mentoring staff is required.
Knowledge/Skills/Attributes:
Excellent knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP ) and local requirements.
Proficiency with computer/software systems.
Excellent verbal, written communication skills and presentation skills.
Excellent organizational, time management, interpersonal, listening, conflict management and negotiation skills.
Ability to prioritize and coordinate multiple tasks and produce quality results in a timely manner with minimal supervision.
Ability to proactively identify issues and address/escalate as appropriate.
Ability to work both independently and in a team environment.
For non-native English speakers: possess excellent skills in written and spoken English.
To apply, click here: http://mapigroup.com/careers/director-clinical-operations-north-america/
As an Equal Opportunity Employer, Mapi is committed to a diverse work force.Estimated Salary: $20 to $28 per hour based on qualifications.
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