clinical research adm.

Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones

Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures

May serve as the primary contact for clinical trial sites (e.g. site management)

Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….)

Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed

Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials

Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel

Interfaces, collaborates and oversees Clinical Research Associates (CRAs)

Oversees and supports the development and execution of Investigator agreements and trial payments

Is responsible for clinical data review to prepare data for statistical analyses and publications

May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need

May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects

May provide on-site procedural protocol compliance and data collection support to the clinical trial sites

Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated

Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)

May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals

May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant

Supports project/study budget activities

May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities)

May perform other duties assigned as needed

Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders

Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures

Should develop a strong understanding of the pipeline, product portfolio and business needs

Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations.

Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or

Biological Science required.

Previous experience in clinical research or equivalent is required.

Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

Clinical/medical background is a plus.

Medical device experience is highly preferred.

Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations

Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations

Good presentation and technical writing skills

Good written and oral English communication skills

Ability to lead small study teams to deliver critical milestones, as may be assigned.

Connect - Develop collaborative relationships with key internal and external stakeholders.

Shape - Make recommendations for and actively participate in departmental process

improvement activities

Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.