Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Manager, Clinical Operations - Remote

Company: SynteractHCR Deutschland GmbH
Location: Carlsbad, CA
Reference: 27354
Closing Date: 19 Feb 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview   The Senior Manager, Clinical Operations (SMCO) is responsible for the line management of assigned direct reports with responsibilities encompassing mentoring, development, training and performance review.  Collaborates with senior management in the on-going development and management of staff in correlation with departmental objectives.  This position can be based in Morrisville, NC, Carlsbad, CA, or home based Anywhere, US.

Requirements:

Overview

 

The Senior Manager, Clinical Operations (SMCO) is responsible for the line management of assigned direct reports with responsibilities encompassing mentoring, development, training and performance review.  Collaborates with senior management in the on-going development and management of staff in correlation with departmental objectives. 

This position can be based in Morrisville, NC, Carlsbad, CA, or home based Anywhere, US. 

 

Responsibilities

  • Mentor, coach, and train direct reports in applicable tasks, responsibilities and regulations.  Ensure appropriate standards are met at all times.
  • Identify individual training needs; ensure compliance with required training as well as the timely completion of training records.
  • In collaboration with department leadership, identify the need for and develop training programs to promote opportunities for employee development, advancement and retention.
  • Discuss and plan career development with direct reports in an on-going manner; provide guidance and assistance wherever possible.
  • Ensure the consistency and quality of direct report performance: measure and report on Key Performance Indicators (KPIs); communicate with direct reports’ project team(s) regarding input on performance; ensure issues and results of discussions are escalated appropriately to Clinical Operations senior management; manage and resolve performance issues. 
  • Hold direct reports accountable for compliance with project plan(s), contractual obligations, applicable company CDs and ethical, regulatory and clinical standards.
  • Hold direct reports accountable for issue escalation to project teams, the Sponsor and QA, as appropriate.
  • Hold at least monthly one-on-one meetings with direct reports to monitor work load and performance, providing on-going feedback and recommendations for improvement and development.
  • Perform regular review of billable hours and utilization for direct reports.  Escalate relevant issues to senior management.
  • Complete and deliver performance appraisals, as required.  Communicate with Clinical Operations senior management and HR to recommend promotion and/or compensation adjustments.
  • Manage direct report time off requests, timesheet and applicable expense report approvals. Review of timesheet includes assessment of accurate recording of time as related to project assignments and tasks.
  • Participate in staff recruitment efforts through interviewing and selection of new clinical personnel together with HR.
  • Conduct onboarding activities; manage induction/orientation modules for new direct report(s) to ensure smooth assimilation to the company.
  • Maintain an awareness of and effectively communicate management strategies, policies and procedures in conjunction with leadership teams.
  • Maintain awareness of overall development in the field of clinical research to ensure that staff remains current on clinical monitoring developments.
  • Develop and maintain effective relationships with Clinical Operations management team to cohesively manage staff.
  • Coordinate and conduct departmental meetings.  Develop and distribute agendas and meeting minutes.
  • Participate in audits as required; oversee follow-up activities and ensure timely implementation and completion of corrective action plans in close cooperation with QA.
  • Contribute to the development and revision of SOPs and standard plans/templates/guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.
  • Liaise with internal and external customers in relevant process improvement initiatives; may assist with the creation and delivery of new department initiatives, improvement plans or training.
  • Conduct accompanied field assessment visits with CRAs as appropriate.
  • Collaborate with other department and /or functional groups to ensure consistency of processes.
  • Provide input to the Clinical Operations portion of proposals, budgets and contracts.
  • Support Business Development with preparation for and attendance at Client meetings, e.g. Capabilities and Bid Defense meetings.
  • Provide mentoring and/or oversight of less experienced Clinical Managers and/or other members of the clinical department.

     

Qualifications

Academic & Professional Qualifications:

  • Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience.
  • 8+ years relevant experience, to include the demonstrated ability to provide guidance and direction to others effectively and/or demonstrated experience in clinical study management, monitoring, and in developing study-related documents.

Skills & Experience:

  • In-depth working knowledge of current ICH-GCP guidelines and applicable regulations.
  • Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
  • Strong communication skills including effective verbal, written and presentation skills; English + local language, if relevant.
  • Strong leadership and interpersonal abilities and organizational skills in a complex and fast paced environment.
  • Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
  • Ability to mentor and train clinical staff.
  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and PowerPoint.
  • This position requires the ability to travel up to 25%.

 

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

 

 


Apply for this job: Senior Manager, Clinical Operations - Remote

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.