Worldwide Clinical Trials

Site Activation Manager

Worldwide Clinical Trials$86K — $170K *
US-AnywhereRemote in Durham, NC
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant scientific field or equivalent experience
  • Four years of experience in clinical research, preferably in CRO or pharmaceutical industry
  • Experience in Start-up Management, Project Management, or Site Management
  • Strong understanding of regulatory processes, ICH GCP, and national guidelines
  • Proficiency in English, both spoken and written

Responsibilities

  • Act as the primary communication point for study start-up and maintenance activities
  • Oversee critical path project activities to meet deadlines and budget
  • Compile, track, and analyze site activation activities accurately
  • Support feasibility and site identification as necessary
  • Develop and maintain site activation project plans jointly with team members
  • Prepare and implement risk assessment and mitigation plans
  • Engage in business development initiatives through proposal contributions

Benefits

  • Comprehensive benefits package depending on location
  • Commitment to pay equity and transparent compensation practices
  • Inclusive and equitable workplace culture
  • Professional development opportunities through training and coaching
  • Opportunity to make a meaningful impact on patients' lives
Full Job Description
*SUMMARY: Accountable for site activation project management and delivery activities within the assigned therapeutic area. Responsibilities include coordination, collaboration and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre award support by providing site activation related input into the proposal text and budget items. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area. RESPONSIBILITIES:* _Tasks may include but are not limited to: _ Serve as the primary point of communication and accountability for study start-up and maintenance (if applicable) activities on assigned projects Oversee project activities of functional groups involved in site activation to ensure critical path activities are completed on-time and within budget Ensure accurate compilation, management, tracking and analysis of site activation activities in a timely manner May support feasibility and/or site identification activities, as needed Work closely with assigned team members to expedite the Site Qualification and Selection process Effectively communicate Site Activation & Regulatory (if applicable) project status to the Sponsor, GPL/CPM and project team Prepare risk assessment and mitigation plans relating to project deliverables with input from other roles Responsible that relevant study activities are present in the work order budget. Ensure OOS activities are tracked and captured within Change Notification Form (CNF) and follow through to execution of change order Work in conjunction with assigned project team members to develop and maintain site activation related project plans May contribute to the development, review, and maintenance of SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department Provide input to departmental process improvement initiatives Establish and interpret site activation metrics to help drive corrective action for achieving deliverables, milestones and/or KPIs May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals, budgets and other country and/or study specific activities related to Site Activation Report and/or escalate issues to Line Manager, Site Activation Portfolio Lead and/or Site Activation Therapeutic Lead to ensure resolution and minimize risks to on-time deliverables Comply with SOPs, ICH GCP and national regulations as applicable Liaise with other functional contributors and vendors as needed Perform other duties as assigned The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. *OTHER SKILLS AND ABILITIES: * Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problems Ability to provide experience and input into initiatives relating to interacting with sites and/or customers Ability to motivate, lead and engage a team Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment Strong oral and written communication skills to clearly and concisely present information Demonstrated ability to collaborate across the business Team-oriented work style; seeks and gives guidance Understanding of regulatory processes and guidelines Understanding of initiation, planning, and execution of clinical projects and overall project planning Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) Ability to handle multiple tasks in a fast-paced and constantly changing environment Ability to work in an organized, methodical, and self-motivated manner Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude *REQUIREMENTS: * A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs) Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience Proficient in cross-cultural communication Proficient in both spoken and written English Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $86,000.00 - $170,000.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. We love knowing that someone is going to have a better life because of the work we do.  To view our other roles, check out our careers page at ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

About Worldwide Clinical Trials

Worldwide Clinical Trials is a global contract research organization (CRO) that provides clinical research services to pharmaceutical and biotechnology companies. They specialize in early phase development, late phase development, and full-service clinical research. Worldwide Clinical Trials has experience in a wide range of therapeutic areas, including oncology, neuroscience, and infectious diseases. They are committed to providing high-quality, efficient, and cost-effective services to their clients.
Learn more about Worldwide Clinical Trials
Size
1,500 employees
Industry
Founded
1986

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