Director Clinical Monitoring

Precision for Medicine is hiring a Director, Clinical Monitoring, the position is working remotely in Poland.

Position Summary:

Responsibilities are focused on the management and career development of the organization’s GCM workforce located in a region/area/therapeutic area as well as leading the development of departmental initiatives to strengthen the quality and productivity of GCM operations. The Director GCM is responsible for financial and quality aspects of the assigned GCM hierarchy. Will lead, manage, and motivate a team of GCM staff to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful and staff achieve the required levels of quality and productivity. In addition, this position will provide the GCM staff with career development and support, to minimize turnover and maintain high levels of employee satisfaction.

Essential functions of the job include but are not limited to:

· Ensure the development and implementation of action plans and provide developmental/strategic oversight to optimize GCM activities, with a focus on high quality delivery and productivity of individual/team/departmental goals.

· Lead regional/therapeutic area project resourcing to ensure proper level and allocation resource is assigned for each project within a region/area.

· Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.

· Develop, mentor, manage and coach GCM Managers to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.

· Oversee GCM quality performance within the assigned hierarchy and implement actions to correct negative trends.

· Support the identification of quality risks and issues and recommend/implement corrective action plans as needed to leadership team to address deficiencies in performance of employees.

· Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.

· Ensure GCM staff within the assigned hierarchy provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.

· Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.

· Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.

· Partner with Talent acquisition to ensure adequate levels of candidates and ad-hoc interview process to select high quality GCM staff.

· Ensure appropriate on-boarding training for new GCM staff in conjunction with Human Resources, Clinical Training and other functional areas.

· Represent Precision for Medicine in a professional manner

· Manage GCM staff in accordance with Precision for Medicine’s values and policies.

· Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.

· Perform other duties as assigned by Leadership

Qualifications:

Minimum Required:

· Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

· At least 12 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.

· Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.

· 6+ years of direct supervisory experience managing CRAs and CRA Managers is expected in candidates for this position including:

· Experience creating effective development programs for clinical staff.

· Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards.

· Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

 

Preferred:

· Experience in the therapeutic area/country of the staff to manage.

 

Competencies:

· Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.

· High capacity for Emotional Intelligence and a passion for people management and development.

· As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs.

· Deep knowledge of how clinical research centers operate along with the ability to teach CRAs and GCM Managers to solve site and execution related problems at the site and project level.

· Demonstrates understanding and ability to work with EMRs and EDCs.

· Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.

· Motivates other members of the project team to meet timelines and project goals.

· Highly organized, ability to set priorities and possesses excellent problem-solving skills.

· Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

· Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.

· Ability to develop, coach and mentor CRA and GCM Management staff.

· Ability to delegate and organize the collective work within the assigned hierarchy.

· Ability to negotiate difficult matters.

· Developing influence as leader within GCM organisation.

· Ability to represent the company at external events, conferences.

· Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.

· Communicates both verbally and in written form in a professional manner.

· Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.

· Possesses practical knowledge of IT tools and systems in use on project teams.

· Values system and work ethic consistent with Precision Values and Company Principles

 

 

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable estimate of the current range for Poland:

402,700 PLN gross per annum to 604,100 PLN gross per annum

 

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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