Senior Clinical Project Manager - DNP
Charlene Dutchman is recruiting for a Senior Clinical Study Manager to join a leading Consumer Healthcare company based in East Yorkshire, on a full time, permanent basis. Our client works with some of the top clinical professional across 60 countries to find better ways to give people innovative solutions for healthier lives.
You will be a senior member of the Clinical Operations team in the Evidence Generation and Clinical Research team, and you will deliver and coach best practices in clinical study conduct, ensuring clinical studies meet business objectives in accordance with statutory requirements.
As a Senior Clinical Study Manager, you will provide clinical input into Healthcare clinical studies and initiatives (US, EU and any other territory in which the company operates) through an understanding of clinical study and regulatory requirements and clinical oversight.
Further responsibilities of this Senior Clinical Study Manager position will include the following:- Lead the study teams for assigned clinical studies in a matrix structure building effective relationships with study teams, ensuring agreed timelines are met.
- Ensure appropriate assessment, selection and management of vendors for outsourced activities.
- Contribute to contract negotiations with vendors.
- Ensure the clinical elements of vendor standard operating procedures are in place and meet local, global and company requirements.
- Ensure the external vendor staff are sufficiently trained and experienced to conduct each specific clinical activity.
- Manage and oversee clinical studies (IMP, device, cosmetics) of low to high complexity in a single country or across multiple regions.
- Ensure study designs and endpoints for planned clinical studies are in line with the required standards (i.e. ICH-GCP, ISO, any local regulatory standards) and are optimal for meeting the study objectives.
- Author or review Protocols, Clinical Study Reports and other various study related documentation.
- Manage and adhere to agreed timelines for studies.
- Manage applicable (vendor) contracts and payments to vendors and manage study budgets.
- Provide regular status reports to Senior Management.
- May perform line management tasks for direct reports assigned including targeted personal and technical development and training.
- Coach other members of the clinical team.
- Assist in keeping the team updated on new clinical methodologies in the Pharmaceutical industry and evaluate whether they should be used in studies.
- Where applicable manage overall resource and study allocation.
- Assist in managing departmental budget for direct reports, if applicable.
- Assist in producing and tracking clinical performance metrics.
- In case of direct reports, ensure the team are sufficiently trained and experienced to conduct each specific clinical activity.
- Collaborate with other regions and actively participate in the globalisation of the team.
As a Senior Clinical Study Manager, you will have the following qualifications, skills and experience:
- Bachelor's or Master's degree in science or a biology-related field with an advanced degree and/or certification preferred or relevant working background.
- Clinical operations/project management background in a clinical or medical department in a pharmaceutical/consumer healthcare/cosmetic industry or at a CRO or clinical vendor.
- In depth and up to date knowledge of GCP/regulatory standards.
- Proven ability of strong project management and organisational capabilities.
- Strong understanding of corporate and operational business needs.
- Computer literacy (Advanced Microsoft Skills).
- Line Management experience preferable.
- Pro-active and self-directed with a high level of initiative and persistence.
- Ability to manage teams from a line management perspective and in a matrix structure.
- Ability to manage priorities.
- Ability to influence without authority.
- Good interpersonal skills, ability to operate successfully in various team capacities and in a multi-cultural environment.
- A clear and logical thinker with the ability to recognise patterns and develop innovative solutions.
- Ability to develop and succinctly communicate strong argumentation in order to influence.
For more information or to apply for this Senior Clinical Study Manager position please contact Charlene Dutchman on 01246 45 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34522 in all correspondence.